TruDi NAV Suction TDNS070ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705031245884), received between Mar 18, 2019 and Feb 24, 2025 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (22 reports).

5 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.

Most reported problems

Recent adverse event reports

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

• 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 ↗
• 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 ↗
• 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 19375207 ↗
• 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 19177539 ↗
• 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 19102182 ↗
• 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 PERF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427698 ↗
• 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 70° TRUDI NAV SUCTION DEVICE, IT HAD BEEN REPROCESSED LESS THAN 10 T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18279613 ↗
• 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 18080757 ↗
• MalfunctionNov 3, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A SINUS PROCEDURE ON (B)(6) 2023, THE PHYSICIAN DID NOT FEEL THAT THE INSTRUMENTS WERE ACCURATE WHILE NAVIGATING. IT WAS REPORTED THAT ¿ALL DEVICES¿ THAT WERE USED DURING THE PROCEDURE WERE INACCURATE, BUT THE PHYSICIAN DID NOT WANT TO TAKE THE TIME TO RE-REGISTER THE PATIENT OR DO ANY TROUBLESHOOTING. IT WAS REPORTED THAT THEY WERE USING ALL NEW SUCTION DEVICES DURING THIS PROCEDURE. NO TROUBLESHOOTING WAS COMPLETED. ANY ADDITIONAL DETAILS REGARDING INACCURACY CANNOT BE OBTAINED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. NO MEDICAL INTERVENTION WAS REQUIRED. THE TRUDI SYSTEM SOFTWARE USED WAS V.2.1.166 THE SERIAL NUMBER OF THE TRUDI NAVIGATION SYSTEM (FG200000) IS (B)(6). ON 17-OCT-2023, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE DEVICES USED FOR THIS PROCEDURE WERE AS FOLLOWS: A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN), A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / LOT# UNKNOWN), A 4.0MM ¿ 15° TRUDI NAVIGATION SHAVER BLADE (TSB415 / LOT# UNKNOWN), AND A TRUDI CURETTE (TDC0005 / LOT# UNKNOWN). THE LOT NUMBER OF THE DEVICES ARE UNKNOWN, PER THE INFORMATION, ¿THE SUCTIONS ARE PRETTY NEW.¿ COMPUTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18069816 ↗
• MalfunctionNov 3, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE, THERE WAS A LOCATION INACCURACY ISSUE WITH ALL THREE SUCTION DEVICES: A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN), A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / LOT# UNKNOWN), AND 90° TRUDI NAV SUCTION DEVICE (TDNS090Z / LOT# UNKNOWN) ON THE TRUDI MONITOR. IT WAS REPORTED THAT THE SUCTIONS APPEARED TO BE APPROXIMATELY 2 TO 3MM OFF. TO TROUBLESHOOT, THE REPORTER OPENED A NEW SET OF SUCTIONS WITHOUT RESOLUTION. THEY RE-REGISTERED THE TRUDI SYSTEM SEVERAL TIMES WITHOUT RESOLUTION. THE SYSTEM WAS ALSO REBOOTED WITHOUT RESOLUTION. THE ISSUE REMAINED UNRESOLVED. FIELD SERVICE ENGINEER FOLLOW-UP WAS REQUESTED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THE TRUDI SYSTEM SOFTWARE USED WAS V.2.3.2..3 THE SERIAL NUMBER OF THE TRUDI NAVIGATION SYSTEM (FG200000) IS (B)(4). ON 30-OCT-2023, ADDITIONAL INFORMATION WAS RECEIVED. RELATED TO THE OVERALL CASE, THE INFORMATION INDICATED THAT THE PATIENT TRACKER WAS NOT MOVED AND THE PATIENT TRACKER CABLE WAS NOT UNDER TENSION. NO FERROMAGNETIC MATERIAL WAS PLACED WITHIN THE TRUDI ZONE. THE EMITTER PAD WAS NOT MOVED AND THE PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067739 ↗
• MalfunctionSep 8, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE ACCLARENT ENT CONSULTANT (ENTC) REPORTED THAT DURING A REVISION BALLOON SINUPLASTY (BSP) / FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE ON (B)(6) 2023, THERE WERE ACCURACY ISSUES ON THE TRUDI SYSTEM FOR ALL THREE (3) TRUDI NAV SUCTION DEVICES: A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / (B)(6)), A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / (B)(6)), AND A 90° TRUDI NAV SUCTION DEVICE (TDNS090Z / (B)(6)). PER THE ENTC, THE PHYSICIAN CHECKED THE SUCTION DEVICES ON ALL BONY AREAS IN THE PROCEDURE AND THE SUCTION DEVICES WERE DISPLAYED INACCURATELY. THE ENTC STATED THAT THE PHYSICIAN MOVED THE SUCTION DEVICE TO THE SPHENOID BACK WALL AND TO THE MAXILLARY BACK WALL, AND THE SUCTION DEVICE WAS DISPLAYED ON THE TRUDI SYSTEM AS INACCURATE. THE PHYSICIAN REPORTED THAT THE SUCTION DEVICES WERE DISPLAYED INACCURATELY ON THE TRUDI SYSTEM BY ABOUT 3 TO 4MM OFF. THE PHYSICIAN DID NOT WANT TO TROUBLESHOOT THE ISSUE AND THE TRUDI SYSTEM WAS NOT REBOOTED. THE PROCEDURE WAS COMPLETED WITHOUT RESOLUTION. THE ENTC REPORTED THAT THE SUCTION DEVICES WERE CONNECTED TO PURPLE INSTRUMENT ADAPTORS IN PORTS 2 AND 4 OF THE INSTRUMENT HUB. REPLACEMENTS FOR ALL THREE SUCTIONS DEVICES WERE REQUESTED. THER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715770 ↗
• MalfunctionAug 3, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE COMPLAINT DEVICE, A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / 2209077) WAS NOT DISPLAYED ACCURATELY ON THE TRUDI SYSTEM. THE DEVICE DISPLAYED A COUPLE OF MILLIMETERS OFF. THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. ON 25-JUL-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE DEVICE GETS REPROCESSED VIA AUTOCLAVE METHOD; HOW MANY TIMES THE COMPLAINT DEVICE HAD BEEN REPROCESSED IS NOT KNOWN. WHEN THE REPORTED ACCURACY WAS OBSERVED, THE COLOR OF THE BAR BELOW THE DEVICE ICON ON THE TRUDI SYSTEM MONITOR WAS GREEN. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAV MONITOR. THE DEVICE WAS PLUGGED IN AFTER REGISTRATION. THE PATIENT TRACKER DID NOT MOVE AND THE PATIENT TRACKER CABLE WAS NOT UNDER TENSION IN RELATION TO THIS EVENT. COMPUTED TOMOGRAPHY (CT) IMAGE WAS USED AS THE PRIMARY IMAGE. THERE WERE 182 SLICES IN THE CT SCAN. THE INFORMATION INDICATED THAT IT WAS THE SURGEON WHO COMPLAINED ABOUT THE ACCURACY ISSUE. THERE WAS NO FERROMAGNETIC MATERIAL PLACED WITHIN THE TRUDI ZONE. THE CROSSHAIRS DID NOT TURN YELLOW. THE EMITTER PAD DID NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17453757 ↗
• MalfunctionJul 5, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A REVISION HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE ON (B)(6) 2023, WHEN THE 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN) WAS INSERTED INTO THE BACK WALL OF THE MAXILLARY SINUS, THE 0° TRUDI NAV SUCTION DEVICE WAS DISPLAYED ON THE TRUDI SYSTEM ABOUT 1 CM ANTERIORLY / POSTERIORLY OFF. THE DEVICE WAS REPLACED WITH A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / LOT# UNKNOWN) AND THE ISSUE PERSISTED. THE INSTRUMENT ADAPTOR WAS ALSO REPLACED WITHOUT RESOLUTION. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITHOUT RESOLUTION; FIELD SERVICE ENGINEER (FSE) FOLLOW-UP WAS REQUESTED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 04-JUL-2023, ADDITIONAL INFORMATION WAS RECEIVED. RELATED TO THE 70° TRUDI NAV SUCTION DEVICE, THE INFORMATION INDICATED THAT THE LOT NUMBER IS NOT AVAILABLE. THE DEVICE HAD BEEN REPROCESSED 20 TIMES; THE STERILIZATION METHOD USED WAS NOT KNOWN. WHEN THE REPORTED ACCURACY ISSUE WAS OBSERVED, THE BAR BELOW THE DEVICE ICON ON THE TRUDI SYSTEM MONITOR WAS GREEN. NO ERROR MESSAGE WAS ON THE TRUDI NAV MONITOR. THE DEVICE WAS PLUGGED IN AFTER REGISTRATION. THE PATIENT TRACKER WAS NOT MOVED; THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17262971 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ENT CONSULTANT REPORTED THAT DURING AN ENT PROCEDURE ON (B)(6) 2023, THAT EMPLOYED THE USE OF THE FOLLOWING ACCLARENT DEVICES: A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / LOT# UNKNOWN), A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN), A 90° TRUDI NAV SUCTION DEVICES (TDNS090Z / LOT# UNKNOWN), AND A TRUDI NAVIGATION SHAVER BLADE (TSB4STR / 230214A-PC) AN ADVERSE EVENT OCCURRED. THE PATIENT SUFFERED A CEREBROSPINAL FLUID (CSF) LEAK DURING THE PROCEDURE. IT WAS REPORTED THAT THE CSF LEAK DID NOT TAKE PLACE DURING THE DEVICE DURING NAVIGATION, HOWEVER, THEY WERE USING TRUDI NAVIGATION DURING THE PROCEDURE. NO INSTRUMENTS WERE BEING USED WHEN THE ADVERSE EVENT WAS NOTICED. THE ENT CONSULTANT ALSO REPORTED THAT DURING THE PROCEDURE, THEY ALSO GOT INTO THE OTHER SIDE OF THE LAMINA (THE ORBIT) OF THE PATIENT WHEN THEY NOTICED THAT THERE WAS A DEHISCENT. IT WAS REPORTED THAT ORBITAL FAT HAD PUNCTURED OUT OF THAT AREA. THERE WAS A LARGE POLYP WITHIN THE MIDDLE MEATUS OF THE NOSE AND WHEN THE PHYSICIAN WAS SHAVING, IT WAS SO THIN AND SO CLOSE TO THE ORBIT, THAT THE YELLOW FATTY PORTION OF THE ORBIT WAS ¿HANGING OUT¿ AND THE PHYSICIAN THEN NOTICED THE DEHISCENCE. IT WAS REPORTED THA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17084011 ↗
• MalfunctionMay 4, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY ON (B)(6) 2023, THE TRUDI NAVIGATION SYSTEM (S/N: (B)(4)), SOFTWARE VERSION 2.3 WAS OFF USING ¿THESE INSTRUMENTS.¿ IT WAS REPORTED THAT THE SUCTION DEVICE WAS REPLACED WITH NO RESOLUTION. THE TRUDI NAV CABLE (TDNC001 / LOT# UNKNOWN) WAS ALSO REPLACED WITH NO RESOLUTION. THE DONGLE WAS ALSO REPLACED WITH NO RESOLUTION. THE ACCLARENT ENT CONSULTANT REPORTED THAT THEY ENCOUNTERED THE SAME ISSUE DURING THE NEXT PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 21-APR-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE ACCLARENT ENT CONSULTANT RETURNED TO THE FACILITY AND TESTED ALL THE SUCTIONS USED IN THE PROCEDURE ON (B)(6) 2023. THE SUCTION DEVICES WERE OFF SIGNIFICANTLY DURING THE TESTING. THE FOLLOWING INFORMATION WAS ALSO PROVIDED: WHEN THE ACCURACY WAS OBSERVED, THE ICON ON THE TRUDI SYSTEM MONITOR WAS GREEN. NO ERROR MESSAGE WAS ON THE TRUDI NAVIGATION MONITOR. THE DEVICE WAS PLUGGED IN AFTER REGISTRATION. THE ENT CONSULTANT STATED THAT THE PATIENT TRACKER DID NOT MOVE AND THE PATIENT TRACKER WAS NOT UNDER TENSION. COMPUTED TOMOGRAPHY (CT) IMA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873385 ↗
• MalfunctionMay 4, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY ON (B)(6) 2023, THE TRUDI NAVIGATION SYSTEM (S/N: (B)(6) ), SOFTWARE VERSION 2.3 WAS OFF USING ¿THESE INSTRUMENTS.¿ IT WAS REPORTED THAT THE SUCTION DEVICE WAS REPLACED WITH NO RESOLUTION. THE TRUDI NAV CABLE (TDNC001 / LOT# UNKNOWN) WAS ALSO REPLACED WITH NO RESOLUTION. THE DONGLE WAS ALSO REPLACED WITH NO RESOLUTION. THE ACCLARENT ENT CONSULTANT REPORTED THAT THEY ENCOUNTERED THE SAME ISSUE DURING THE NEXT PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 21-APR-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE ACCLARENT ENT CONSULTANT RETURNED TO THE FACILITY AND TESTED ALL THE SUCTIONS USED IN THE PROCEDURE ON (B)(6) 2023. THE SUCTION DEVICES WERE OFF SIGNIFICANTLY DURING THE TESTING. THE FOLLOWING INFORMATION WAS ALSO PROVIDED: WHEN THE ACCURACY WAS OBSERVED, THE ICON ON THE TRUDI SYSTEM MONITOR WAS GREEN. NO ERROR MESSAGE WAS ON THE TRUDI NAVIGATION MONITOR. THE DEVICE WAS PLUGGED IN AFTER REGISTRATION. THE ENT CONSULTANT STATED THAT THE PATIENT TRACKER DID NOT MOVE AND THE PATIENT TRACKER WAS NOT UNDER TENSION. COMPUTED TOMOGRAPHY (CT) IM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873382 ↗
• MalfunctionApr 14, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INABILITY TO SWITCH VENTILATION MODES AS EXPECTED DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747859 ↗
• MalfunctionApr 5, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY ENDOSCOPIC SINUS SURGERY PROCEDURE, THE TRUDI NAVIGATION SYSTEM ACCURACY WAS OFF BY ABOUT 2 CM. THE 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN), THE 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / LOT# UNKNOWN), AND THE TRUDI NAVIGATION SHAVER BLADE (CATALOG / LOT# UNKNOWN) WERE ALL OFF IN ACCURACY BY 2 CM. THE PATIENT WAS RE-REGISTERED MULTIPLE TIMES WITHOUT RESOLUTION. THE PATIENT TRACKER WAS RE-SEATED ON THE PATIENT¿S FOREHEAD WITHOUT RESOLUTION. THE REGISTRATION PROBE WAS REPLACED WITHOUT RESOLUTION. IT WAS REPORTED THAT THE PROCEDURE WAS CONTINUED WITHOUT USING ANY NAVIGATION. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 22-MAR-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT WHEN THE ACCURACY ISSUE WAS OBSERVED WITH THE 70° TRUDI NAV SUCTION DEVICE, ALL DEVICES SHOWED GREEN IN MULTIPLE PORTS. ¿THERE WAS NEVER ANY ERROR MESSAGE ON THE TRUDI OF ANY KIND.¿ THE PATIENT TRACKER DID NOT MOVE DURING THE PROCEDURE. THE INFORMATION INDICATED THAT THE COMPUTED TOMOGRAPHY (CT) SCAN CONTAINS ABOUT 200 SLICES; THE SCANS WERE 1 MM AND 0.9 MM RESPECTIVELY. IT WAS ALSO REPORTED THAT ¿NOTHING WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686685 ↗
• MalfunctionMar 6, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / 2103237) STOPPED TRACKING ON THE TRUDI NAVIGATION SYSTEM. THE SUCTION DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED; THE PROCEDURE CONTINUED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 16-FEB-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE 70° TRUDI NAV SUCTION DEVICE WAS REPROCESSED, HOWEVER, THE NUMBER OF TIME IT HAD BEEN REPROCESSED WAS NOT AVAILABLE / KNOWN BY REPORTER. STERILIZATION METHOD USED IS PER INSTRUCTIONS FOR USE (IFU) RECOMMENDATION. WHEN THE REPORTED ISSUE OF THE SUCTION DEVICE NOT TRACKING WAS OBSERVED, THE ICON ON THE TRUDI NAVIGATION MONITOR WAS GREEN. RELATING TO WHETHER THERE WAS ANY ERROR MESSAGE ON THE TRUDI NAVIGATION MONITOR, THE INFORMATION INDICATED THAT ¿THEY DID NOT MENTION WHAT THE ERROR MESSAGE SAID.¿ THE SUCTION DEVICE WAS PLUGGED IN AFTER REGISTRATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 16-FEB-2023, THE EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER TITLE 21 CFR 203 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16487347 ↗
• MalfunctionFeb 27, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE TRUDI NAVIGATION SYSTEM WAS SHOWING INACCURACIES DURING THE PROCEDURE. THE 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / 2112087) WAS USED AND THE INACCURACY WAS REPORTED TO BE 3MM TO 5MM OFF ANTERIORLY. THE ICON ON THE TRUDI NAV WAS GREEN WHEN THE INACCURACY ISSUE WAS NOTED. THERE WAS NO ERROR MESSAGE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT OR PATIENT INJURY. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS); THERE WERE NO NON-ACCLARENT DEVICES USED. THE 70° TRUDI NAV SUCTION DEVICE HAD BEEN REPROCESSED APPROXIMATELY 15 TIMES VIA THE AUTOMATED METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449080 ↗
• MalfunctionJan 31, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE ON (B)(6) 2023, THE TRUDI SYSTEM WAS NOT TRACKING THE TRUDI PROBE 70, 5IN (TDP0705 / LOT# UNKNOWN), THE 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN), AND THE 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / LOT# UNKNOWN) WELL WHILE THE DEVICES WERE IN BOTH MAXILLARY SINUSES. THE REPORTED TRACKING ISSUE WAS DISCOVERED WHILE CHECKING ACCURACY ALONG THE POSTERIOR AND LATERAL WALL OF THE MAXILLARY SINUSES THAT THE TRUDI PROBE AND THE TWO SUCTION DEVICES WERE BOTH DISPLAYED INACCURATELY ON THE TRUDI SYSTEM BY ABOUT 5MM OFF. IT WAS ALSO REPORTED THAT THE TRUDI PROBE AND THE TWO SUCTION DEVICES WERE ALSO INACCURATELY DISPLAYED IN THE SPHENOID, ETHMOID, AND FRONTAL SINUSES. TROUBLESHOOTING WAS NOT PERFORMED. THE INDICATOR LIGHTS ON THE TRUDI SYSTEM FOR THE INSTRUMENTS WERE ALWAYS DISPLAYED AS GREEN. THE PROCEDURE WAS REPORTED AS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT INJURY. ON 23-JAN-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT ACCURACY WAS CONFIRMED USING THE REGISTRATION PROBE AFTER THE REGISTRATION PROCESS WAS COMPLETED. AFTER REGISTRATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274808 ↗
• MalfunctionJan 9, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE TRUDI SYSTEM FUNCTIONAL ASSESSMENT MEASURE (FAM) WILL NOT CONTINUE TO RECORD WHEN A NAVIGATED DEVICE IS CONNECTED. IT WAS REPORTED THAT THIS IS AN ONGOING ISSUE. TO RESOLVE THIS ISSUE, THE FAM WINDOW NEEDS TO BE OPENED/CLOSED. ONCE THE FAM WINDOW IS REOPENED, THEY ARE ABLE TO START THE FAM RECORDING AGAIN. THE HEALTHCARE PROFESSIONAL REPORTED THAT THIS ISSUE OCCURS EVERY TIME A NEW NAVIGATED DEVICE IS CONNECTED TO THE TRUDI SYSTEM. THE HEALTHCARE PROFESSIONAL ALSO REPORTED THAT THERE IS A BOUT A 3MM FLOATING INACCURACY THAT IS MOST PROMINENT POSTERIORLY. THEY TESTED WITH THE REGISTRATION PROBE AND TWO SUCTION DEVICES, A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / 2208310) AND A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / 2209077), AND THE ISSUE IS PRESENT ON BOTH SUCTION DEVICES. THE PATIENT TRACKER WAS CONFIRMED TO BE WITHIN THE ZONE AND THERE WAS NO METAL INTERFERENCE. NO ADDITIONAL TROUBLESHOOTING WAS PERFORMED. THE HEALTHCARE PROFESSIONAL CONFIRMED THAT THE PHYSICIAN TOUCHED SEVERAL PARTS OF THE ANATOMY WITH THE REGISTRATION PROBE, AND THE ISSUE IS NOT PRESENT ON THE SU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122337 ↗
• MalfunctionSep 30, 2022Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A HYBRID REVISION FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, IT WAS REPORTED THAT THE 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / 2112030) WAS INACCURATE ON THE TRUDI NAVIGATION SYSTEM. THEY EXCHANGED THE SUCTION DEVICE FOR ANOTHER 0° TRUDI NAV SUCTION DEVICE FROM THE SAME LOT NUMBER, (TDNS000Z / 2112030) AND THE ISSUE REPORTEDLY PERSISTED. IT WAS REPORTED THAT THE SECOND 0° TRUDI NAV SUCTION DEVICE WAS REPLACED WITH A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / 2112087) AND THE SAME ISSUE PERSISTED. THE 70° TRUDI NAV SUCTION DEVICE WAS REPLACED WITH A 90° TRUDI NAV SUCTION DEVICE (TDNS090Z / 2109179) AND THE SAME ISSUE PERSISTED. THE PATIENT TRACKER WAS THEN EXCHANGED; THE REPLACEMENT PATIENT TRACKER WAS RE-REGISTERED AND TRIED WITH TWO (2) DIFFERENT NAVIGATION CABLES, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS CONTINUED WITHOUT ANY FURTHER TROUBLESHOOTING. THE PHYSICIAN IS AWARE OF THE INACCURACIES. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION AS A RESULT OF THE REPORTED INACCURACIES. ON (B)(6)2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE ACCURACY ISSUE WAS NOTICED IMM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15515175 ↗
• MalfunctionJun 15, 2022Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE ACCLARENT REPRESENTATIVE REPORTED THAT A MALE PATIENT SUFFERED A CEREBROSPINAL FLUID (CSF) LEAK DURING A PRIMARY BILATERAL FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT AFTER REGISTRATION OF THE DEVICE, EVERYTHING LOOKED ACCURATE. THE PHYSICIAN COMPLETED THE PROCEDURE ON THE PATIENT¿S LEFT SIDE WITH NO ISSUES. THE PHYSICIAN PROCEEDED TO DO A SEPTOPLASTY PROCEDURE ON THE RIGHT SIDE, AT THIS POINT IN THE PROCEDURE, THE ACCLARENT REPRESENTATIVE STEPPED OUT OF THE ROOM. THE REPRESENTATIVE WAS CALLED BACK INTO THE ROOM BY THE PHYSICIAN WHEN THEY DISCOVERED THE CSF LEAK. IT WAS REPORTED THAT IN THE PHYSICIAN¿S OPINION, ¿THEY HAD ENTERED THE SKULL BASE THINKING IT WAS THE ETHMOID CELL.¿ IT WAS REPORTED THAT THE PHYSICIAN ¿PACKED IT¿ (THE CSF LEAK) AND USED DURACIL ON IT. THE PHYSICIAN THEN COMPLETED THE PROCEDURE AND THE PATIENT WAS SENT TO THE HOSPITAL FOR A COMPUTED TOMOGRAPHY (CT) SCAN AND OBSERVATION. AS OF THE TIME OF THE CALL, THE ACCLARENT REPRESENTATIVE REPORTED THAT THE PHYSICIAN WAS TOLD BY THE EMERGENCY SURGEON THAT THE CT SCAN ¿LOOKED FINE¿ AND THE PATIENT WAS ¿RESPONDING WELL.¿ THE ACCLARENT REPRESENTATIVE REPORTED THAT AFTER THE CSF LEAK WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14700568 ↗
• MalfunctionMar 18, 2019Calibration Problem; Calibration Problem

  ON (B)(6) 2019 ACCLARENT IDENTIFIED 3 LOTS OF TRUDI¿ NAV SUCTION INSTRUMENTS (0°, 70° & 90°) THAT WERE DISTRIBUTED TO CUSTOMERS HAD A CALIBRATION ISSUE IN ONE OF THEIR COMPONENTS. THIS CALIBRATION ISSUE CAUSED AN INCORRECT TIP ORIENTATION DISPLAY IN THE TRUDI¿ SYSTEM THAT IS USED IN CONJUNCTION WITH THE DEVICE. THE SURGEON STILL HAS A FUNCTIONING ENDOSCOPIC VIEW IN ADDITION TO THE LOCATION FEATURE OF THE TRUDI¿ SYSTEM. NO ADVERSE EVENTS HAVE BEEN REPORTED FOR THIS INCIDENT. ON (B)(6) 2019 ACCLARENT INITIATED A REMOVAL OF THESE LOTS IN THE FIELD FOR THE POTENTIAL SAFETY RISK ASSOCIATED WITH THE INCORRECT TIP ORIENTATION DISPLAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8429160 ↗

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-2507-2024 · Jul 9, 2024 · Open, Classified
  TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in E
• 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-0824-2020 · Mar 6, 2019 · Terminated
  TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
• Z-0825-2020 · Mar 6, 2019 · Terminated
  TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
• Z-0826-2020 · Mar 6, 2019 · Terminated
  TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891