TruDi NAV Suction TDNS000ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10705031245877), received between Jul 30, 2019 and Dec 10, 2025 — classified as 5 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (54 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K180948); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 9, 2024Class IIOpen, Classified

   Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.

   Z-2507-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Connection Problem; Connection Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767586 ↗
• MalfunctionMar 25, 2025Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) IN AN OPERATION ROOM (OR). THE TRUDI NAVIGATION SYSTEM DISPLAYED INACCURACY OF 2.5MM WITH A TRUDI SUCTION DEVICE (TDNS000Z, LOT UNKNOWN) AND A TRUDI SHAVER (PRODUCT CODE AND LOT UNKNOWN). THE CALLER STATED THEY RE-REGISTERED THE PATIENT 3 TIMES WITHOUT RESOLUTION. THE CALLER STATED THE PROCEDURE CONTINUED WITH THE ISSUE UNRESOLVED. NON ACCLARENT DEVICES WERE NOT USED. THERE WAS NO PATIENT INJURY AND THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION AS A RESULT THE ALLEGED PRODUCT ISSUE. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-MAR-2025 INDICATED THAT CUSTOMER CONFIRM ACCURACY USING THE REGISTRATION PROBE AFTER REGISTRATION PROCESS WAS COMPLETED. THE CUSTOMER CONFIRMED ACCURACY KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY. INACCURACY WITH THE ACCLARENT (ACR) INSTRUMENTS WERE FIRST DETERMINED IN THE MAX WALL. ACCURACY WAS VALIDATED USING BOTH THE REGISTRATION PROBE AND THROUGH INSTRUMENTATION. CT IMAGE WAS USED AS THE PRIMARY IMAGE. THERE WERE NO NOTICEABLE DEFECTS TO THE CT SCANNED IMAGE. THE VIEW WAS AXIAL. THE SURGEON PERFORMED THE REGISTRATION, HAS BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687995 ↗
• MalfunctionFeb 24, 2025Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT MIDWAY THROUGH A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) IN THE OPERATING ROOM (OR), A TRUDI SYSTEM LOST ACCURACY. IT WAS STATED THAT THE TRUDI SUCTION DEVICE (TDNS000Z, LOT UNKNOWN) AND A TRUDI SHAVER BLADE - STRAIGHT, DOUBLE SERRATED, 4.0MM X 110MM (TSB4STR, LOT UNKNOWN) WERE INACCURATELY DISPLAYED ON THE TRUDI SYSTEM. THE CALLER STATED THAT THE ISSUE OCCURRED TWICE DURING THE CASE. IT WAS NOTED THAT EACH TIME THE ISSUE OCCURRED, REGISTERING THE PATIENT WOULD RESOLVE THE ISSUE. THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUES. THERE WAS NO ALLEGATION THAT A DEATH OR SERIOUS INJURY OCCURRED DUE TO THE USE OF THE PRODUCT. THERE WAS NO REPORT OF THE PATIENT REQUIRING MEDICAL INTERVENTION. NON ACCLARENT DEVICES WERE USED. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-FEB-2025 INDICATED THAT THE CUSTOMER CONFIRMED ACCURACY USING THE REGISTRATION PROBE AFTER REGISTRATION PROCESS WAS COMPLETED. THE CUSTOMER CONFIRM ACCURACY MULTIPLE TIMES IN THE KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY. DURING THE SURGICAL PROCEDURE, THE SURGEON WAS NOTICING THAT THE ACCURACY WAS OFF AND STOPPED AND CHECKED. THE INACCURACY WAS F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21450360 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT A FUNCTIONAL ENDOSCOPIC SINUS SURGERY, AND IT WAS REPORTED THAT THE PATIENT WAS NOT WAKING UP AFTER THE PROCEDURE. THE PATIENT¿S OXYGEN SATURATION LEVEL DROPPED ABOUT 5 TO 10 MINUTES AFTER THE PROCEDURE WAS COMPLETED. THEY HAD TO ¿JAW THRUST¿ THE PATIENT AND ¿BAGGING THE PATIENT¿ WITHOUT SUCCESS. THE PATIENT¿S OXYGEN LEVEL DROPPED TO 40% AND 50%. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED, AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. INFORMATION REGARDING ANY MEDICAL INTERVENTION IS NOT AVAILABLE AT THE TIME OF THE COMPLAINT INITIATION. THE DEVICES THAT WERE USED DURING THE PROCEDURE WERE A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN), A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / LOT# UNKNOWN). THE SOFTWARE VERSION ON THE TRUDI NAVIGATION SYSTEM IS VERSION 2.3.3.29. OTHER DEVICES THAT WERE USED WERE A 4.MM X 110MM STRAIGHT, DOUBLE SERRATED BIEN AIR SHAVER BLADE, AND A 4.0MM 40-DEGREE CURVED DOUBLE SERRATED CONCAVE BIEN AIR SHAVER BLADE. ON 19-FEB-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PATIENT WAS STABLE DURING THE PROCEDURE. THERE WAS NO ISSUE RELATED TO THE BIEN AIR DEVICE USED DURING THE PROCEDURE THAT

  Patient problems: Hypoxia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447495 ↗
• MalfunctionFeb 12, 2025Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT MIDWAY THROUGH A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), POSTERIOR AND SUPERIOR, THERE WERE ACCURACY ISSUES ON THE TRUDI SYSTEM FOR A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z, LOT UNKNOWN), A 70 TRUDI NAV SUCTION DEVICE (TDNS000Z, LOT UNKNOWN) AND A TRUDI PROBE (UNKNOWN PRODUCT CODE/LOT). THE INACCURACY WAS OFF ABOUT ONE CENTIMETER. THE PATIENT WAS RE-REGISTERED, WHICH TEMPORARILY RESOLVED THIS ISSUE. BUT THE ISSUE OCCURRED LATER IN THE PROCEDURE. THE PHYSICIAN DID NOT ADDRESS ONE OF THE FRONTAL SINUSES DUE TO THE ISSUE. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 20-JAN-2025 INDICATING THAT THE CUSTOMER CONFIRMED ACCURACY USING THE REGISTRATION PROBE AFTER REGISTRATION PROCESS WAS COMPLETED. THE CUSTOMER CONFIRMED ACCURACY KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY. INACCURACY WAS DETERMINED BY THE SUCTION BEING USED TO LOCATE THE SKULL BASE AND IT WAS OFF. WE PULLED A NAVIGATION PROBE AND IT WAS OFF AS WELL. THE USER REGISTERED AGAIN ONCE WE SAW THAT THE NAVIGATION WAS OFF. WE WERE ACCURATE ANTERIORLY BUT AS WE WENT POSTERIOR AND SUPERIOR THE NAVIGATION WAS OFF. SIX COMPUTED TOMOGRAPHY (CT) IMAGES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366141 ↗
• MalfunctionFeb 12, 2025Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT MIDWAY THROUGH A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), POSTERIOR AND SUPERIOR, THERE WERE ACCURACY ISSUES ON THE TRUDI SYSTEM FOR A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z, LOT UNKNOWN), A 70 TRUDI NAV SUCTION DEVICE (TDNS000Z, LOT UNKNOWN) AND A TRUDI PROBE (UNKNOWN PRODUCT CODE/LOT). THE INACCURACY WAS OFF ABOUT ONE CENTIMETER. THE PATIENT WAS RE-REGISTERED, WHICH TEMPORARILY RESOLVED THIS ISSUE. BUT THE ISSUE OCCURRED LATER IN THE PROCEDURE. THE PHYSICIAN DID NOT ADDRESS ONE OF THE FRONTAL SINUSES DUE TO THE ISSUE. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 20-JAN-2025 INDICATING THAT THE CUSTOMER CONFIRMED ACCURACY USING THE REGISTRATION PROBE AFTER REGISTRATION PROCESS WAS COMPLETED. THE CUSTOMER CONFIRMED ACCURACY KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY. INACCURACY WAS DETERMINED BY THE SUCTION BEING USED TO LOCATE THE SKULL BASE AND IT WAS OFF. WE PULLED A NAVIGATION PROBE AND IT WAS OFF AS WELL. THE USER REGISTERED AGAIN ONCE WE SAW THAT THE NAVIGATION WAS OFF. WE WERE ACCURATE ANTERIORLY BUT AS WE WENT POSTERIOR AND SUPERIOR THE NAVIGATION WAS OFF. SIX COMPUTED TOMOGRAPHY (CT) IMAGES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366015 ↗
• MalfunctionFeb 7, 2025Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT MIDWAY THROUGH A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) WITH BALLOON DILATION IN THE OPERATING ROOM, A TRUDI SYSTEM LOST ACCURACY. IT WAS STATED THAT THE TRUDI SUCTION DEVICE (TDNS000Z, LOT UNKNWO), THE TRUDI SHAVER BLADE ¿ STRAIGHT, DOUBLE SERRATED, 4.0MM X 110MM (TSB4STR, UNKNOWN LOT) AND A RELEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM, 6X16MM (RSP0616MFSN, UNKNOWN LOT) WERE INACCURATELY DISPLAYED ON THE TRUDI SYSTEM. THE CALLER STATED THAT THE ISSUE OCCURRED THREE TIMES DURING THE CASE. THE PATIENT WAS REREGISTERED THE FIRST TWO TIMES THE ISSUE OCCURRED, AND THE ISSUE WOULD BE RESOLVED. THE THIRD TIME THAT THE ISSUE OCCURRED, THE PROCEDURE WAS CONTINUED WITHOUT RESOLUTION. THERE WAS NO ALLEGATION THAT A DEATH OR SERIOUS INJURY OCCURRED DUE TO THE USE OF THE PRODUCT. THERE WAS NO REPORT OF THE PATIENT REQUIRING MEDICAL INTERVENTION. NON ACCLARENT DEVICES WERE USED. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-FEB-2025 INDICATED THAT THE CUSTOMER CONFIRMED ACCURACY USING THE REGISTRATION PROBE AFTER REGISTRATION PROCESS WAS COMPLETED. THE CUSTOMER CONFIRM ACCURACY MULTIPLE TIMES IN THE KNOWN LANDMARKS IN ENDOSCOPIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334672 ↗
• MalfunctionNov 7, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT, DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THERE WAS A ISSUE WITH THE REGISTRATION ACCURACY OF TRUDI SUCTION, 0 - 1PK (TDNS000Z, LOT UNKNOWN). THE CALLER STATES THAT THE PHYSICIAN REPORTS THAT THE NAVIGANT TOOLS DO NOT ALIGN WITH THE INITIAL REGISTRATION DURING THE PROCEDURE. THERE WAS NO ALLEGATION THAT A DEATH OR SERIOUS INJURY OCCURRED DUE TO THE USE OF THE PRODUCT. THERE WAS NO REPORT OF THE PATIENT REQUIRING MEDICAL INTERVENTION AS A RESULT THE ALLEGED PRODUCT ISSUE. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 16-OCT-2024 INDICATING THAT THE CUSTOMER CONFIRM ACCURACY USING THE REGISTRATION PROBE AFTER REGISTRATION PROCESS WAS COMPLETED. THE CUSTOMER CONFIRMED ACCURACY KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY. THE INACCURACY WAS DETERMINED WHEN PLACING THE NAVIGABLE INSTRUMENTS IN THE NOSE. THE INACCURACY WAS FIRST NOTICED UPON PLACING A STRAIGHT SUCTION INTO THE NOSE. THE ACCURACY VALIDATED WAS USED BY BOTH THE REGISTRATION PROBE AND THROUGH INSTRUMENTATION. THE CT IMAGE USED AS THE PRIMARY IMAGE AND THERE WERE NO NOTICEABLE DEFECTS TO THE CT SCANNED IMAGE. THE REGISTRATION WAS P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20635306 ↗
• MalfunctionOct 2, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REVISION FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE ACCURACY WAS OFF BY 7 MM. THE REGISTRATION PROBE AND THE 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / 2402140) WERE REPLACED AND THE ACCURACY WAS STILL OFF, BUT ¿IT WAS MORE ACCURATE THAN BEFORE.¿ THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. AFTER THE PROCEDURE, A MODEL HEAD WAS USED TO PERFORM EXTENSIVE TROUBLESHOOTING. ON 01-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE END USER DID CONFIRM ACCURACY USING THE REGISTRATION PROBE (S/N: (B)(6)) AFTER THE REGISTRATION PROCESS WAS COMPLETED. THE END USER CONFIRMED ACCURACY USING KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY ¿AND IT LOOKED INACCURATE.¿ INACCURACY WAS DETERMINED USING FUNCTIONAL ASSESSMENT MEASURE (FAM) ON THE TRUDI SYSTEM WITH THE SUCTION AND THEN MEASURED THE INACCURACY WITH THE MEASURING TOOL ON THE TRUDI SYSTEM. INACCURACY WAS FIRST NOTICED WHEN THE END USER LOOKED WITH INSTRUMENTS ON [THE] MODEL HEAD AFTER THE CASE. THERE WAS NO NOTICEABLE DEFECTS TO THE COMPUTED TOMOGRAPHY (CT) SCANNED IMAGE. THE ADDITIONAL INFORMATION INDICA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20354121 ↗
• MalfunctionJul 19, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE TRUDI NAVIGATION SYSTEM WAS NOT ACCURATE, USING TWO TRUDI SUCTION, 0 - 1PK (TDNS000Z, UNKNOWN LOT) AND TRUDI SUCTION, 70 - 1PK (TDNS070Z, LOT UNKNOWN). THE CALLER NOTED THAT THE TRUDI MAP WAS OFF ANTERIORLY BY APPROXIMATELY 5 MMS. NO TROUBLESHOOTING WAS MENTIONED. THE REPORTER NOTED THAT THEY CONTINUED THE CASE WITH THE INACCURATE MAP. SEVERAL PARTS HAD PREVIOUSLY BEEN REPLACED AND THE ISSUE STILL REOCCURRED. REGISTRATION PROBE & THE SUCTIONS WERE NOT ACCURATE ACCORDING TO THE SURGEON. TRUDI SYSTEM SOFTWARE VERSION: 2.3.2.3. A SHAVER BLADE WAS USED. THERE WAS NO ALLEGATION THAT A DEATH OR SERIOUS INJURY OCCURRED DUE TO THE USE OF THE PRODUCT. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE EVENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 08-JUL-2024 INDICATED THAT THE CUSTOMER CONFIRMED ACCURACY USING THE REGISTRATION PROBE AFTER REGISTRATION PROCESS WAS COMPLETED. THE INACCURACY WAS DETERMINED BY ORBITAL RIM BONE. THE INACCURACY WAS FIRST NOTICED AT REGISTRATION. REGISTRATION PROBE AND THE SUCTIONS WERE NOT ACCURATE ACCORDING TO THE SURGEON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19783109 ↗
• MalfunctionJul 19, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ETHMOIDECTOMY WITH BALLOON SINUPLASTY, THE SUCTION DEVICE, TRUDI SUCTION, 0 - 1PK (TDNS000Z, LOT UNKNOWN) WAS BEING DISPLAYED INACCURATELY ON THE TRUDI NAV SYSTEM. THE CALLER NOTED A 4-5 MM INACCURACY OF THE DEVICE. THE CALLER BELIEVES THIS IS DUE TO THE FAULTY SUCTION DEVICE. THE CALLER NOTED THAT ALL OTHER NAVIGATION DEVICES WERE BEING DISPLAYED PROPERLY. THE FACILITY DID NOT HAVE A SPARE SUCTION DEVICE TO TROUBLESHOOT THE ISSUE FURTHER. THE CASE CONTINUED WITH THE ISSUE. THERE WAS NO ALLEGATION THAT A DEATH OR SERIOUS INJURY OCCURRED DUE TO THE USE OF THE PRODUCT. THERE WAS NO REPORT OF THE PATIENT REQUIRING MEDICAL INTERVENTION. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 09-JUL-2024 INDICATING THAT THE PATIENT TRACKER WAS NOT MOVED NOR WAS THE PATIENT TRACKER UNDER TENSION IN RELATION TO THIS EVENT. NO MORE THAN ONE CT SCAN WAS ATTEMPTED TO BE USED WITH ONE DEVICE. THE CT IMAGE USED AS THE PRIMARY IMAGE. THE CT SCAN OBTAINED ¿ENOUGH¿ SLICES. NO FERROMAGNETIC MATERIAL WAS PLACED WITHIN THE TRUDI ZONE. THE EMITTER PAD WAS NOT MOVED. THERE WAS NO OTHER DEVICE¿S SHAFT IN PROXIMITY TO AN EMITTER PAD¿S TRANSMITTER. THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781724 ↗
• MalfunctionJul 1, 2024Display or Visual Feedback Problem; Incorrect Interpretation of Signal; Display or Visual Feedback Problem; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL WAS AT THE HOSPITAL AND WAS INFORMED THAT PRIOR TO THE START OF AN ENT (EAR, NOSE & THROAT) PROCEDURE, THE 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / 2212120) ¿WAS BAD.¿ THE REPORTER PLUGGED IN THE SUCTION ¿ NOT DURING THE PROCEDURE, AND THE SUCTION DEVICE WOULD NOT WORK. THE DEVICE SHOWED 20 USES. IT DID NOT GIVE AN ERROR CODE ¿ ¿IT TURNED GREEN ON THE SCREEN ¿ IT JUST WOULD NOT WORK.¿ THERE WAS NO PATIENT INVOLVEMENT AS THE PROCEDURE HAS NOT STARTED WHEN THE DEVICE WAS TESTED. ON 28-JUN-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE 0° TRUDI NAV SUCTION DEVICE WOULD NOT TRACK ON THE TRUDI SCREEN. ¿IT SHOWED GREEN ON THE CONSOLE AND THE MONITOR ¿ BUT DID NOT NAVIGATE.¿ BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 28-JUN-2024, THE EVENT HAS BEEN DEEMED REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652054 ↗
• MalfunctionJun 3, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, ACCURACY WAS "OFF" BY ABOUT 10MM ON THE TRUDI NAVIGATION SYSTEM. THE CALLER STATED IT WAS ONLY WHILE USING THE TRUDI SUCTION, 0-1PK ((B)(6), LOT UNKNOWN) DEVICE. THE CALLER REPLACED THE SUCTION DEVICE WITH ANOTHER UNSPECIFIED DEVICE (PRODUCT AND LOT NUMBERS UNAVAILABLE) BUT THE ISSUE PERSISTED. THE PATIENT DID NOT EXPERIENCE ADVERSE EVENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-MAY-2024 INDICATED THAT THE CUSTOMER CONFIRMED ACCURACY USING THE REGISTRATION PROBE AFTER REGISTRATION PROCESS WAS COMPLETED. THE CUSTOMER CONFIRMED ACCURACY KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY, THE NASOPHARYNX WAS CHECKED. THE INACCURACY WAS NOTICED AS SOON AS THEY ENTERED ENDOSCOPICALLY. ACCURACY WAS VALIDATED USING BOTH THE PROBE AND THROUGH INSTRUMENTATION. ACCURATE WITH PROBE AND INACCURATE ENDOSCOPICALLY AND POSTERIOR. CT IMAGE USED AS PRIMARY IMAGE. ALL FIELD VIEWS WERE AVAILABLE. THERE WERE NO NOTICEABLE DEFECTS TO THE CT SCANNED IMAGE. THE PHYSICIAN PERFORMED THE REGISTRATION AND HAS PERFORMED MANY IN THE PAST. THIS WAS NOT THE USER¿S FIRST-TIME WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449253 ↗
• MalfunctionMay 24, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THERE WAS INACCURATE ISSUES WITH TRUDI SUCTION, 0 - 1PK (TDNS000Z, 2207120) ON (B)(6) 2024 AND AGAIN ON 30-APR-2024. THE INACCURACY WAS 4-5MM. REREGISTER THE PATIENT BUT THE ISSUE REMAINED. THE CALLER WANTED TO TRY A NEW DEVICE, AND OPENED UP A TRUDI PROBE, 70, 5IN, THE PROBE WAS ACCURATE AND PRESENTED NO PROBLEMS. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ADDITIONAL EVENT INFORMATION RECEIVED ON 02-MAY-2024 INDICATED THAT THE PATIENT TRACKER WAS NOT MOVED NOR WAS THE PATIENT TRACKER UNDER TENSION IN RELATION TO THIS EVENT, BUT SUCTION WAS MOST LIKELY THE ISSUE, SINCE SAME INACCURACY WAS NOTED ON 30-APR-2024 WITH THE SAME 0 DEGREE SUCTION. ON (B)(6) 2024, THE SALES REPRESENTATIVE RE-REGISTERED 2 TIMES. NO MORE THAN ONE CT SCAN WAS ATTEMPTED TO BE USED WITH ONE DEVICE. THE CT IMAGE USED AS THE PRIMARY IMAGE. THE SLICES ON THE CT CONTAINED <1 MM SLICES ON BOTH DATES. NO FERROMAGNETIC MATERIAL WAS PLACED WITHIN THE TRUDI ZONE. THE EMITTER PAD WAS NOT MOVED FOR BOTH DATES. THERE WAS NO OTHER DEVICE¿S SHAFT IN PROXIMITY TO AN EMITTER PAD¿S TRANSMITTER. THE SERIAL NUMBER FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392303 ↗
• MalfunctionMay 22, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REVISION BILATERAL FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE ON (B)(6) 2024, ACCURACY WAS REPORTED TO BE OFF ON THE TRUDI SYSTEM AND SHIFTED TO THE LEFT SIDE OF THE PATIENT. THE TWO SUCTION DEVICES: 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN) AND 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / LOT# UNKNOWN), AND THE 4.0MM ¿ STRAIGHT (0°) TRUDI NAVIGATION SHAVER BLADE (TSB4STR / LOT# UNKNOWN) HAD ACCURACY ISSUES. NO TROUBLESHOOTING WAS PERFORMED. THE PROCEDURE CONTINUED WITHOUT RESOLUTION. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 14-MAY-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE ADDITIONAL INFORMATION, ACCURACY WAS CONFIRMED USING THE REGISTRATION PROBE AFTER THE REGISTRATION WAS COMPLETED. THE END USER CONFIRMED ACCURACY USING KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY. ACCURACY WAS DETERMINED BY CHECKING ON KNOWN LANDMARKS. THE INACCURACY WAS FIRST NOTICED WHEN CHECKING IN THE SPHENOID WALL. ACCURACY WAS VALIDATED USING BOTH THE REGISTRATION PROBE AND THROUGH INSTRUMENTATION. COMPUTED TOMOGRAPHY (CT) IMAGE WAS USED AS THE PRIMARY IMAGE. THE CT SCAN CONTAINED 100+ SLICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375201 ↗
• MalfunctionMay 21, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THERE WAS AN INACCURATE SUCTION WITH ABOUT 4-5MM WHEN USING A TRUDI SUCTION, 0 - 1PK (TDNS000Z, 2207120), REGISTERED THE PATIENT TWICE, BUT THE ISSUE REMAINED. THE PHYSICIAN STOPPED USING NAVIGATION AND COMPLETED WITHOUT NAVIGATION. THE CALLER STATED THAT ON THAT DAY THERE WAS NOTHING ELSE DONE. NO NON ACCLARENT DEVICES WERE USED. THE ACCLARENT DEVICE(S) DID NOT FUNCTION AS EXPECTED. THERE WAS NO ALLEGATION THAT A DEATH OR SERIOUS INJURY OCCURRED DUE TO THE USE OF THE PRODUCT. THERE WAS NO REPORT OF THE PATIENT REQUIRING MEDICAL INTERVENTION AS A RESULT THE ALLEGED PRODUCT ISSUE. ADDITIONAL EVENT INFORMATION RECEIVED ON 30-APR-2024 INDICATED THE PATIENT TRACKER MOVED OR THE PATIENT TRACKER CABLE UNDER TENSION IN RELATION TO THIS EVENT, HOWEVER IT WAS FIXED, AND WE RE-REGISTERED. THE COMPUTED TOMOGRAPHY (CT) SCAN WAS GOOD. UNABLE TO SPECIFIED HOW MANY SLICES DID THE CT SCAN CONTAINED, BUT IT WAS SUB 2MM. THERE WAS NO FERROMAGNETIC MATERIAL PLACED WITHIN THE TRUDI ZONE. THE EMITTER PAD DID NOT MOVE NOR DID THE PATIENT MOVE. THERE WAS NO OTHER DEVICE¿S SHAFT IN PROXIMITY TO AN EMITTER PAD¿S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19361583 ↗
• MalfunctionMay 6, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID BILATERAL FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) AND BALLOON SINUPLASTY (BSP) PROCEDURE ON (B)(6) 2024, UPON STARTING THE TRUDI SYSTEM, THE CONSOLE WAS DISPLAYED AS RED AND AN INSTRUMENT HUB CALIBRATION ERROR (UNKNOWN CODE) WAS DISPLAYED ON THE TRUDI SYSTEM. THE TRUDI SYSTEM WAS REBOOTED AND THE ISSUE WAS RESOLVED. THE PROCEDURE RESUMED. IT WAS ALSO REPORTED THAT THE ACCURACY WAS OFF BY APPROXIMATELY 4MM. THE 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN), 4.0MM ¿ STRAIGHT (0°) TRUDI NAVIGATION SHAVER BLADE (TSB4STR / LOT# UNKNOWN), AND 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / LOT# UNKNOWN) HAD ACCURACY ISSUES. NO TROUBLESHOOTING WAS PERFORMED. THE PROCEDURE WAS CONTINUED WITHOUT RESOLUTION. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. THERE WAS NO MEDICAL INTERVENTION REQUIRED NOR REPORTED AS A RESULT OF THE REPORTED ISSUE WITH ACCURACY. ON 03-MAY-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE ADDITIONAL INFORMATION, ACCURACY WAS CONFIRMED BEFORE USING THE REGISTRATION PROBE AFTER THE REGISTRATION PROCESS WAS COMPLETED. ACCURACY WAS CONFIRMED VIA KNOWN LANDMARK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256246 ↗
• MalfunctionApr 25, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REVISION PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE, THE ACCURACY OF THE DEVICES WERE OFF BY APPROXIMATELY 4MM ALONG THE SKULL BASE AND THE SPHENOID SINUS. THE REPORTED ACCURACY ISSUE AFFECTED A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN), A CURVED SUCTION DEVICE (CATALOG / LOT# UNKNOWN), AND A 4MM ZERO-DEGREE SHAVER BLADE (CATALOG / LOT # UNKNOWN). NO TROUBLESHOOTING WAS PERFORMED. THE PROCEDURE CONTINUED WITHOUT RESOLUTION. IT WAS REPORTED THAT THIS WAS A RECURRING ISSUE IN THE TRUDI SYSTEM (S/N: 100121). THE SOFTWARE VERSION USED WAS CONFIRMED TO BE 2.3.3. THE REPORTER WAS UNABLE TO PROVIDE ANY INFORMATION RELATED TO THE DISPOSABLE DEVICE THAT HAD ACCURACY ISSUES; THE SUCTION DEVICES ARE RETAINED BY THE SITE AND THE SHAVER BLADE WAS DISCARDED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THE PATIENT¿S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE ¿FINE.¿ THE PATIENT¿S MOST CURRENT STATUS IS REPORTED TO BE ¿FINE.¿ ON 24-APR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, ACCURACY WAS CONFIRMED USING THE REGISTRATION PROBE AFTER REGISTRATION PROCESS WAS COMPLETED. ACCURACY WAS CONFIRM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19188643 ↗
• MalfunctionApr 24, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE HYBRID BALLOON SINUPLASTY (BSP) PROCEDURE WITH SHAVER, THE PHYSICIAN FELT THAT THERE WAS A VARIETY OF INACCURACIES BETWEEN THE DIFFERENT INSTRUMENTS THAT WERE USED. THE INSTRUMENTS USED WERE THE FOLLOWING: A 4.0MM ¿ 15° TRUDI NAVIGATION SHAVER BLADE (TSB415 / 240117C-PC), A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / 2308140), A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / 2309057), A 90° TRUDI NAV SUCTION DEVICE (TDNS090Z / 2312269), AN ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM (PVT0616N / 82284217), AND A TRUDI NAV CABLE (TDNC001 / 240304D-PC) THAT WAS USED FOR THE SUCTIONS. HOW MUCH INACCURACY WAS OBSERVED / PRESENT COULD NOT BE CONFIRMED. THE PROCEDURE REPORTEDLY CONTINUED WITHOUT ANY TROUBLESHOOTING. THE SOFTWARE VALUE TO BE V2.3.2.3, BUT THE CALLER DID NOT HAVE THE FULL VERSION. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. NONE OF THE COMPLAINT PRODUCTS ARE AVAILABLE FOR RETURN. ON 24-APR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PHYSICIAN¿S OFFICE STAFF MEMBER REGISTERED THE CASE. HOW THE INACCURACY WAS DETERMINED COULD NOT BE CONFIRMED. THE INACCURACY WAS FIRST NOTICED WHEN THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177537 ↗
• MalfunctionApr 12, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID BILATERAL FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, ACCURACY WAS OFF BY OVER 4MM ON THE TRUDI SYSTEM. THE 0° TRUDI NAV SUCTION DEVICE (TDNS000Z), 70° TRUDI NAV SUCTION DEVICE (TDNS070Z), AND 4.0MM ¿ 15° TRUDI NAVIGATION SHAVER BLADE (TSB415) WERE AFFECTED BY THE ACCURACY ISSUES. THE PATIENT WAS RE-REGISTERED TWO MORE TIMES, BUT THE ISSUE PERSISTED. THE PROCEDURE CONTINUED WITHOUT RESOLUTION. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 11-APR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, ACCURACY WAS CONFIRMED USING THE REGISTRATION PROBE AFTER THE REGISTRATION PROCESS WAS COMPLETED. THE END USER DID CONFIRM ACCURACY KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY. INACCURACY WAS DETERMINED BY PLACING THE SUCTION DEVICE INSIDE THE NOSE AND TESTING. INACCURACY WAS FIRST NOTICED WHEN PLACING SUCTION ON THE MIDDLE [TURBINATE] AND IT SHOWED THEY WERE ON [INFERIOR TURBINATE]. ACCURACY WAS VALIDATED USING BOTH REGISTRATION PROBE AND INSTRUMENTATION. COMPUTED TOMOGRAPHY (CT) IMAGE WAS USED AS THE PRIMARY IMAGE. FIELD OF VIEW WAS AXIAL. THERE WERE NO NOTICEABLE DEFE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102178 ↗
• MalfunctionJan 2, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE ON (B)(6) 2023, ACCURACY WAS OFF BY ABOUT 5-6MM. THE REPORTER STATED THAT THE INACCURACY OCCURRED ON THREE TRUDI NAVIGATION SUCTION DEVICES. ONE OF THESE THREE DEVICES ALSO HAD AN ¿ERROR CODE¿. THE DEVICES WITH THE ALLEGED PRODUCT MALFUNCTION WERE A TRUDI SUCTION, 0 - 1PK (TDNS000Z, 2207120032), TRUDI SUCTION, 0 - 1PK (TDNS000Z, LOT UNKNOWN) AND A TRUDI SUCTION, 70 - 1PK (TDNS070Z, LOT UNKNOWN). ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PHYSICIAN PERFORMED THE REGISTRATION. THE CUSTOMER CONFIRMED ACCURACY WAS PERFORMED BY USING THE REGISTRATION PROBE AFTER REGISTRATION PROCESS WAS COMPLETED. THE CUSTOMER CONFIRMED ACCURACY KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY. THE INACCURACY WAS DETERMINED WHEN CONFIRMING ACCURACY ON KNOWN ANATOMY LANDMARKS, UNICANTE, MAX WALL. THE EVENT OCCURRED AT THE START OF THE CASE. THE INACCURACY WAS NOTICED BY USING THE REGISTRATION PROBE WITH INSTRUMENTATION. THEY PLUGGED IN THE DEVICES AFTER REGISTRATION. WHEN THE ACCURACY ISSUE WAS OBSERVED, THE ICON ON THE TRUDI NAV SYSTEM WAS GREEN. CT SCAN WAS PER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427705 ↗
• MalfunctionJan 2, 2024Incorrect Interpretation of Signal; Communication or Transmission Problem; Incorrect Interpretation of Signal; Communication or Transmission Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE ON (B)(6)2023, ACCURACY WAS OFF BY ABOUT 5-6MM. THE REPORTER STATED THAT THE INACCURACY OCCURRED ON THREE TRUDI NAVIGATION SUCTION DEVICES. ONE OF THESE THREE DEVICES ALSO HAD AN ¿ERROR CODE¿. THE DEVICES WITH THE ALLEGED PRODUCT MALFUNCTION WERE A TRUDI SUCTION, 0 - 1PK (TDNS000Z, (B)(6) TRUDI SUCTION, 0 - 1PK (TDNS000Z, LOT UNKNOWN) AND A TRUDI SUCTION, 70 - 1PK (TDNS070Z, LOT UNKNOWN). ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PHYSICIAN PERFORMED THE REGISTRATION. THE CUSTOMER CONFIRMED ACCURACY WAS PERFORMED BY USING THE REGISTRATION PROBE AFTER REGISTRATION PROCESS WAS COMPLETED. THE CUSTOMER CONFIRMED ACCURACY KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY. THE INACCURACY WAS DETERMINED WHEN CONFIRMING ACCURACY ON KNOWN ANATOMY LANDMARKS, UNICANTE, MAX WALL. THE EVENT OCCURRED AT THE START OF THE CASE. THE INACCURACY WAS NOTICED BY USING THE REGISTRATION PROBE WITH INSTRUMENTATION. THEY PLUGGED IN THE DEVICES AFTER REGISTRATION. WHEN THE ACCURACY ISSUE WAS OBSERVED, THE ICON ON THE TRUDI NAV SYSTEM WAS GREEN. CT SCAN WAS PERFORMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427684 ↗
• InjuryDec 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ENT (EAR, NOSE & THROAT) PROCEDURE WITH ACCLARENT DEVICES SUFFERED A CSF LEAK DURING THE PROCEDURE. THE PHYSICIAN STATED THAT THEY WERE "POKING AROUND IN THE FRONTAL SINUS, THE PATIENT HAD A THIN SKULL BASE," AND THERE WAS A PUNCTURE. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY PATCH THE SITE, AND THE PATIENT WAS TRANSFERRED TO HOSPITAL FOR FOLLOW-UP. THE CALLER STATED THAT A STRAIGHT SUCTION MAY HAVE BEEN THE PRODUCT IN USE, BUT THEY WERE NOT SURE. THE DEVICE IS UNAVAILABLE FOR RETURN.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 18346797 ↗
• MalfunctionDec 6, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY BILATERAL FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE PHYSICIAN FELT THAT THE ACCURACY OF THE SUCTION DEVICES, A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN) AND A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / LOT# UNKNOWN) WERE OFF BY AS MUCH AS 2MM. THE REPORTER STATED THAT A SHAVER THAT WAS BEING USED WAS COMPLETELY ACCURATE, BUT THE SUCTION DEVICES WERE NOT. NO OTHER ISSUES WITH THE OTHER DEVICES WERE REPORTED. PER THE REPORTER, THE SUCTION DEVICES WERE NOT REPLACED TO CONTINUE WITH THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. ON 22-NOV-2023, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PATIENT TRACKER DID NOT MOVE AND THE PATIENT TRACKER CABLE WAS NOT UNDER TENSION IN RELATION TO THE REPORTED ISSUES. COMPUTED TOMOGRAPHY (CT) IMAGE WAS USED AS THE PRIMARY IMAGE. THERE WAS NO FERROMAGNETIC MATERIAL PLACED WITHIN THE TRUDI ZONE. THE TRANSMITTER OF THE EMITTER PAD DID NOT MOVE. THE EMITTER PAD DID NOT MOVE. THE SERIAL NUMBER OF THE TRUDI SYSTEM USED IS 400092. THE SOFTWARE VERSION USED WAS 2.3.2.3. RELATED TO THE 0° TRUDI NAV SUCTION DEVICE, IT HAD BEEN REPROCESSED LESS THAN 10 TI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18279612 ↗
• MalfunctionNov 6, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY BILATERAL HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THERE WERE ¿3-4 TIMES INTERMITTENTLY THROUGHOUT THE PROCEDURE, A RED PATIENT TRACKER FOR PORT 4 WAS DISPLAYED ON THE TRUDI SYSTEM EVEN THOUGH A 0-DEGREE SUCTION DEVICE WAS CONNECTOR TO PORT 4 OF THE INSTRUMENT HUB.¿ IT WAS NOTED THAT THE PATIENT TRACKER WAS CONNECTED TO PORT 1 OF THE INSTRUMENT HUB. WHEN THE ISSUE OCCURRED, THE SUCTION DEVICE LOST THE ABILITY TO NAVIGATE. IT WAS REPORTED THAT THE ISSUE WOULD BE RESOLVED ON ITS OWN; THE ICON DISPLAYED ON THE TRUDI SYSTEM FOR PORT 4 ¿WOULD SPIN LIKE IT WAS THINKING / LOADING AND GO BACK TO THE SUCTION DEVICE.¿ NO TROUBLE SHOOTING WAS PERFORMED. ALL THE DEVICES USED: A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN), A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / LOT# UNKNOWN), A TRUDI CURETTE (TDC0005 / LOT# UNKNOWN), AND A 4.0MM ¿ STRAIGHT (0°) TRUDI NAVIGATION SHAVER BLADE (TSB4STR / LOT# UNKNOWN) WERE INACCURATELY DISPLAYED ON THE TRUDI SYSTEM BY ABOUT 4MM. THEY REGISTERED THE PATIENT MID-PROCEDURE, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS CONTINUED WITHOUT RESOLUTION. THE SOFTWARE VERSION USED WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080756 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180948. One submission often covers many models, so check the product and lot details in each record.

• Z-0415-2022 · Nov 12, 2021 · Open, Classified
  TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
• Z-0826-2020 · Mar 6, 2019 · Terminated
  TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
• Z-0825-2020 · Mar 6, 2019 · Terminated
  TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
• Z-0824-2020 · Mar 6, 2019 · Terminated
  TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877