TruDi NAV SuctionRecalls & reported problems across all models

We found 3 models of TruDi NAV Suction by Acclarent, Inc. in the FDA's device registry (GUDID). Together they are named in 100 adverse event reports in the FDA's MAUDE database, received between Mar 18, 2019 and Dec 10, 2025 — classified as 11 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (82 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

TruDi NAV Suction recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 9, 2024Open, 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 TruDi NAV Suction problems

TruDi NAV Suction models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TruDi NAV Suction TDNS000Z

  Ear, Nose, and Throat Stereotaxic Instrument
  1 recall61 reports
• TruDi NAV Suction TDNS070Z

  Ear, Nose, and Throat Stereotaxic Instrument
  25 reports
• TruDi NAV Suction TDNS090Z

  Ear, Nose, and Throat Stereotaxic Instrument
  14 reports

Recent TruDi NAV Suction adverse event reports

The 15 most recent reports across all models, 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 21447498 ↗
• 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 ↗
• InjuryFeb 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRUDI¿ NAVIGATION CASE IN THE OPERATING ROOM (OR), A CEREBROSPINAL FLUID OR CSF LEAK WAS NOTICED IN THE PATIENT. THE CALLER REPORTED THAT THERE WERE NO ISSUES OR ERRORS OBSERVED ON THE TRUDI¿ NAVIGATION SYSTEM. THE CALLER REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN HAD NOTICED A SMALL CEREBROSPINAL FLUID LEAK IN THE PATIENT. THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A MUCOSAL PATCH OR GRAFT. THE CALLER REPORTED THAT THE PATIENT WAS THEN SENT TO THE HOSPITAL FOR FURTHER MONITORING. THE CALLER WAS UNABLE TO CONFIRM IF THE PATIENT IS IN STABLE CONDITION AT THIS TIME. IT WAS ALSO REPORTED THAT THE FOLLOWING ACCLARENT PRODUCTS WERE USED DURING THIS CASE: RELIEVA SPINPLUS® NAV BALLOON - RSP0616MFSN, TRUDI¿ PROBE (70 DEGREE) - TDP0705, TRUDI¿ NAV SUCTION DEVICE (0 DEGREE) - TDNS000Z, TRUDI¿ NAV SUCTION DEVICE (70 DEGREE) - TDNS070Z, TRUDI¿ NAV SUCTION DEVICE (90 DEGREE) - TDNS090Z.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 21367238 ↗
• InjuryFeb 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRUDI¿ NAVIGATION CASE IN THE OPERATING ROOM (OR), A CEREBROSPINAL FLUID OR CSF LEAK WAS NOTICED IN THE PATIENT. THE CALLER REPORTED THAT THERE WERE NO ISSUES OR ERRORS OBSERVED ON THE TRUDI¿ NAVIGATION SYSTEM. THE CALLER REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN HAD NOTICED A SMALL CEREBROSPINAL FLUID LEAK IN THE PATIENT. THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A MUCOSAL PATCH OR GRAFT. THE CALLER REPORTED THAT THE PATIENT WAS THEN SENT TO THE HOSPITAL FOR FURTHER MONITORING. THE CALLER WAS UNABLE TO CONFIRM IF THE PATIENT IS IN STABLE CONDITION AT THIS TIME. IT WAS ALSO REPORTED THAT THE FOLLOWING ACCLARENT PRODUCTS WERE USED DURING THIS CASE: RELIEVA SPINPLUS® NAV BALLOON - RSP0616MFSN. TRUDI¿ PROBE (70 DEGREE) - TDP0705. TRUDI¿ NAV SUCTION DEVICE (0 DEGREE) - TDNS000Z. TRUDI¿ NAV SUCTION DEVICE (70 DEGREE) - TDNS070Z. TRUDI¿ NAV SUCTION DEVICE (90 DEGREE) - TDNS090Z.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 21367081 ↗
• InjuryFeb 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRUDI¿ NAVIGATION CASE IN THE OPERATING ROOM (OR), A CEREBROSPINAL FLUID OR CSF LEAK WAS NOTICED IN THE PATIENT. THE CALLER REPORTED THAT THERE WERE NO ISSUES OR ERRORS OBSERVED ON THE TRUDI¿ NAVIGATION SYSTEM. THE CALLER REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN HAD NOTICED A SMALL CEREBROSPINAL FLUID LEAK IN THE PATIENT. THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A MUCOSAL PATCH OR GRAFT. THE CALLER REPORTED THAT THE PATIENT WAS THEN SENT TO THE HOSPITAL FOR FURTHER MONITORING. THE CALLER WAS UNABLE TO CONFIRM IF THE PATIENT IS IN STABLE CONDITION AT THIS TIME. IT WAS ALSO REPORTED THAT THE FOLLOWING ACCLARENT PRODUCTS WERE USED DURING THIS CASE: RELIEVA SPINPLUS® NAV BALLOON - (B)(6). TRUDI¿ PROBE (70 DEGREE) - T(B)(6). TRUDI¿ NAV SUCTION DEVICE (0 DEGREE) - (B)(6). TRUDI¿ NAV SUCTION DEVICE (70 DEGREE) - (B)(6). TRUDI¿ NAV SUCTION DEVICE (90 DEGREE) - (B)(6).

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 21366720 ↗
• 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 19783295 ↗
• 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 ↗

Other Acclarent, Inc. products

• INSPIRA AIR4 models · 9 reports · 1 recall
• RELIEVA SPINPLUS NAV2 models · 29 reports
• TruDi Shaver Blade3 models · 24 reports