TruDi NAV Suction TDNS090ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031245891), received between Mar 18, 2019 and Feb 12, 2025 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionApr 26, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE 90° TRUDI NAV SUCTION DEVICE (TDNS090Z / 2208299) STOPPED NAVIGATING. IT WAS REPORTED THAT WHEN THE SUCTION DEVICE WAS IN THE ZONE, THE ICON FOR THE SUCTION DEVICE WAS GREEN, BUT THEY WERE UNABLE TO VISUALIZE THE SUCTION DEVICE ON THE TRUDI SYSTEM. THE NAVIGATION CABLE WAS REPLACED, BUT THE ISSUE PERSISTED. THE SUCTION DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE STERILIZATION METHOD USED WAS AS ¿PER IFU.¿ THE NUMBER OF TIMES THE DEVICE HAS BEEN REPROCESSED CANNOT BE DETERMINED FOR CERTAIN, BUT IT WAS ¿LESS THAN 20¿ TIMES. THE DEVICE ICON WAS GREEN BUT [THE DEVICE] WAS NOT NAVIGATING. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAV MONITOR. THE DEVICE WAS PLUGGED IN BEFORE REGISTRATION. THE INFORMATION INDICATED THE SUCTION DEVICE WAS A 90-DEGREE SUCTION DEVICE. ON 25-APR-2024, THE CORRECT SERIAL NUMBER (B)(6) OF THE DEVICE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19195760 ↗
• 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 19177538 ↗
• MalfunctionApr 10, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE 90° TRUDI NAV SUCTION DEVICE (TDNS090Z / 2206109) WAS NOT NAVIGATING PROPERLY ON THE TRUDI NAVIGATION SYSTEM. THE 90° TRUDI NAV SUCTION DEVICE IS UNDER 30 USES. WHEN THE SUCTION DEVICE WAS REPLACED, THE ISSUE WAS RESOLVED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 09-APR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE STERILIZATION METHOD OF THE 90° TRUDI NAV SUCTION DEVICE CANNOT BE CONFIRMED. THE REPORTED ISSUE THAT THE DEVICE WAS NOT NAVIGATING PROPERLY OCCURRED DURING USE. WHEN THE ISSUE WAS OBSERVED, THE COLOR OF THE ICON OF THE DEVICE ON THE TRUDI SYSTEM WAS GREEN. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAV MONITOR FOR THE DEVICE. THE 90° TRUDI NAV SUCTION DEVICE WAS PLUGGED IN AFTER REGISTRATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 09-APR-2024, THE REPORTED NAVIGATION ISSUE HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19084202 ↗
• 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)(6). 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 18067735 ↗
• 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 / 2208160), A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / 2210147), AND A 90° TRUDI NAV SUCTION DEVICE (TDNS090Z / 2209159). 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. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715771 ↗
• 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

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17084010 ↗
• 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 (B)(6) 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 16873388 ↗
• 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 (B)(6) 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 16873387 ↗
• 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 IM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15515090 ↗
• MalfunctionMar 28, 2019Calibration Problem; Calibration Problem

  ON (B)(4) 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)(4) 2019 ACCLARENT INITIATED A REMOVAL OF THESE LOTS IN THE FIELD FOR THE POTENTIAL SAFETY RISK ASSOCIATED WITH THE INCORRECT TIP ORIENTATION DISPLAY. THE 90-DEGREE TRUDI NAVIGATION SUCTION DEVICE (TDNS090Z / 1901219) ASSOCIATED WITH THIS COMPLAINT IS FROM ONE OF THE THREE LOTS IDENTIFIED WITH THE CALIBRATION ISSUE IN ONE OF THE COMPONENTS. THE CALIBRATION ISSUE WAS NOT NOTICED DURING THE CASE, A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE ON (B)(6) 2019; THE ISSUE WAS VERIFIED THE FOLLOWING DAY ON (B)(6) 2019, AFTER TESTING THE SUCTION FUNCTION ON THE SYSTEM. THE PRODUCT WAS RETURNED AS PART OF THE AFFECTED LOT UNDER A STOP SHIPMENT NOTIFICATION. THERE WAS NO REPORT OF ANY PATIENT INJURY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8462459 ↗
• 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 MARCH 5, 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 8429157 ↗

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-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