TruDi Shaver Blade TSB4STRRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031469235), received between Apr 5, 2023 and Sep 11, 2025 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (8 reports).

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED THAT THE TRUDI SHAVER BLADE - 0 DEGREE (TSB4STR) JAW FEATURE, BROKE OFF DURING USE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). WHILE SHAVING THE ETHMOID SINUSES, THE JAW FEATURE THAT ROTATES REPORTEDLY POPPED OFF INTO THE PATIENT'S SINUS DURING SHAVING DISSECTION. THE PART WAS REMOVED. IT WAS REPORTED THAT THE ORIGO (DEVICE USED WITH THE TRUDI SHAVER BLADE) WAS WORKING AS NORMAL; NOTHING WAS NOTICEABLY WRONG AND NO ABNORMALITIES IN THE SINUSES WERE NOTED. IT TOOK TEN (10) MINUTES FOR STAFF TO RETRIEVE DEVICE PIECES AND OPEN A NEW DEVICE. IT WAS REPORTED THAT NO PATIENT INJURY OR DEATH OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025654 ↗
• MalfunctionApr 30, 2025Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS SIGNIFICANT INACCURACY ON THE TRUDI NAVIGATION SYSTEM DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) IN THE OPERATING ROOM (OR). DURING INITIAL REGISTRATION THE TRUDI PROBE, 0, 5IN (TDP0005, 230926A-PC) DID NOT INITIALLY RECOGNIZE THE FIDUCIAL POINTS, AND WHILE TRACING THE REGISTRATION PROBE GREEN LINES WERE NO LONGER APPEARING GREEN. TO TROUBLESHOOT, THE CALLER RESTARTED THE SYSTEM, THIS RESOLVED THE REGISTRATION ISSUE, THE PROBE WAS WORKING. THEN, MID-CASE THE ACCURACY OF THE INSTRUMENTS WAS "SIGNIFICANTLY OFF." THEY TRIED USING A NEW SUCTION, A NEW TRUDI SHAVER BLADE - STRAIGHT, DOUBLE SERRATED, 4.0MM X 110MM (TSB4STR, 250107F-PC), A NEW PROBE, THEY REREGISTERED, TRIED USING A NEW DISPOSABLE PATIENT TRACKER, ALL WITHOUT RESOLUTION. THE SUCTION DEVICE USED WAS GREATER THAN 30 USES, OUT OF WARRANTY BUT THIS DID NOT EXPLAIN THE OTHER ACCURACY ISSUES. THE CASE 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936636 ↗
• 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 21449867 ↗
• 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 21334949 ↗
• MalfunctionJul 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 FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, AFTER COMPLETING THE REGISTRATION AND CONNECTING THE TRUDI NAVIGATED SHAVER BLADE (TSB4STR / LOT# UNKNOWN), IT WAS NOTICED THAT THE TRUDI NAVIGATED SHAVER BLADE ACCURACY WAS OFF ON THE TRUDI NAVIGATION SYSTEM. THE TRUDI NAVIGATED SHAVER BLADE WAS THEN RECONNECTED TO A DIFFERENT PORT ON THE INSTRUMENT HUB, AND THEN THE TRUDI NAVIGATION SYSTEM DISPLAYED ERROR 3109, NAVIGATED DEVICE ERROR. THE TRUDI NAVIGATED SHAVER BLADE WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS RESUMED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 01-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE COMPUTED TOMOGRAPHY (CT) IMAGE WAS USED AS THE PRIMARY IMAGE. IT IS NOT KNOWN HOW MANY SLICES THE CT SCAN CONTAINED. THERE WAS NOT MORE THAN ONE CT SCAN ATTEMPTED TO BE USED WITH ONE DEVICE. THE PATIENT TRACKER DID NOT MOVE. THE PATIENT TRACKER CABLE WAS NOT UNDER TENSION IN RELATION TO THIS EVENT. THERE WAS NO FERROMAGNETIC MATERIAL PLACED WITHIN THE TRUDI ZONE. THE EMITTER PAD DID NOT MOVE. THE PATIENT DID NOT MOVE. THE SERIAL NUMBER OF THE TRUDI SYSTEM IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19659631 ↗
• MalfunctionJun 5, 2024Incorrect Interpretation of Signal; Communication or Transmission Problem; Incorrect Interpretation of Signal; Communication or Transmission Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A HYBRID REVISION BILATERAL FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, AFTER PLUGGING IN THE 4.0MM ¿ STRAIGHT (0°) TRUDI NAVIGATION SHAVER BLADE (TSB4STR / 240312C-PC), AN ERROR DISPLAYED ON THE TRUDI SYSTEM THAT SAID, ¿NAVIGATED DEVICE ERROR PLEASE REPLACE THE DEVICE.¿ THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS RESUMED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 20-MAY-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE SERIAL NUMBER OF THE TRUDI NAVIGATION SYSTEM (FG200000) IS (B)(6). SOFTWARE VERSION WAS 2.3.3. ACCURACY WAS CONFIRMED USING THE REGISTRATION PROBE AFTER THE REGISTRATION PROCESS WAS COMPLETED. ACCURACY WAS CONFIRMED USING KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY. INACCURACY WAS DETERMINED BY CHECKING INSIDE THE NOSE WHEN TESTING ON THE MAXILLARY AND SPHENOID WALLS. ACCURACY WAS VALIDATED USING BOTH THE REGISTRATION PROBE AND THROUGH INSTRUMENTATION. COMPUTED TOMOGRAPHY (CT) IMAGE WAS USED AS THE PRIMARY IMAGE. THE FIELD OF VIEW WAS AXIAL. THERE WAS NO NOTICEABLE DEFECTS TO THE CT SCANNED IMAGE. IT WAS THE PHYSICIAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19473229 ↗
• 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 19375205 ↗
• 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 19256244 ↗
• MalfunctionMar 5, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, WHEN THEY WERE IN THE PATIENT¿S ANATOMY, THE SHAVER BLADE IMAGES OF A TRUDI SHAVER BLADE 4.0MM - STRAIGHT (0°)- 5PK (TSB4STR) BEGAN FLICKERING AND FREEZING ON THE TRUDI MONITOR. A WHITE DONGLE WAS USED WHEN THE ISSUE OCCURRED. NO TROUBLESHOOTING WAS PERFORMED. THE ISSUE REMAINS UNRESOLVED. NO NON ACCLARENT DEVICES WERE USED. 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 OF THE ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838059 ↗
• MalfunctionDec 4, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE SCREEN ON THE TRUDI SYSTEM WOULD FLICKER ¿EVERY ONCE IN A WHILE AND THE TRUDI SHAVER BLADE ICON WOULD DISAPPEAR AND REAPPEAR.¿ WHEN THE SURGEON WAS IN THE PATIENT¿S NOSE, THE TRUDI SHAVER BLADE, A 4.0MM ¿ STRAIGHT (0°) TRUDI NAVIGATION SHAVER BLADE SB4STR / (B)(4) SUDDENLY DISAPPEARED FROM THE SCREEN WITH NO FLICKERING. THE REPORTER RESEATED THE SHAVER BLADE AND THEN THE SHAVER BLADE ICON CHANGED TO ORANGE AND THE REPORTER BELIEVES THAT THERE WAS A SENSOR ERROR ON THE SHAVER BLADE. THE COMPLAINT SHAVER BLADE WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18263697 ↗
• InjuryDec 4, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ENT (EAR, NOSE & THROAT PROCEDURE) WITH ACCELERANT DEVICES (TRUDI SHAVER BLADE 4.0MM - STRAIGHT (0°)- 5PK) EXPERIENCED PROFUSION BLEEDING. IT WAS REPORTED WHILE SHAVING WITH THE TRUDI 4MM SHAVER BLADE IN THE SPHENOID SINUS THE DOCTOR HIT "SOMETHING" AND THE PATIENT STARTED BLEEDING PROFUSELY. IT WAS ALSO REPORTED THAT THE PHYSICIAN HAD TO PACK THE PATIENT'S NOSE AND SUCTION THE BLOOD OUT OF THE MOUTH. CALLER STATED AFTER THE BLEEDING STOPPED, THEY REMOVED THE PACKING AND THE PATIENT STARTED BLEEDING PROFUSELY AGAIN SO THEY REPACKED THE PATIENT'S NOSE AND DID NOT REMOVE IT. IT WAS REPORTED THAT THE PATIENT WAS KEPT INTUBATED AND THEN SENT THEM WITH EMS TO THE EMERGENCY ROOM. IT WAS ALSO NOTED THAT THE ACCURACY ON THE TRUDI NAVIGATION SYSTEM HAD NO ISSUES WITH ACCURACY AND WORKED AS INTENDED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON NOV 22, 2023, PER THE INFORMATION PROVIDED IT WAS DETERMINED FROM A CT SCAN OF THE PATIENT THAT THE SURGEON HAD HIT THE CAROTID. THE SURGEON ALSO MENTIONED THAT THERE WAS A DEHISCENCE NEAR THE SKULL BASE THAT WAS DETECTED AFTER THE ADVERSE EVENT OCCURRED. IT WAS NOTED THAT THE PATIENT IS DOING WELL WITH NO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18258778 ↗
• 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 18080762 ↗
• MalfunctionNov 1, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENT (EAR, NOSE & THROAT) PROCEDURE, THE 4.0MM ¿ STRAIGHT (0°) TRUDI NAVIGATION SHAVER BLADE (TSB4STR / 230608A-PC) AND THE 4.0MM - 60° CURVED TRUDI NAVIGATION SHAVER BLADE (TSB460 / 230720A-PC) WERE SHOWING INTERMITTENT FLASHING ON THE TRUDI NAVIGATION SYSTEM (FG200000 / SERIAL NUMBER: (B)(6) WHILE IN USE. THE TRUDI NAVIGATION SYSTEM WAS RUNNING SOFTWARE VERSION 2.3.1. IT WAS REPORTED THAT THE ICON WAS ¿ALMOST JUMPING¿ DURING THE PROCEDURE. THE TRUDI SCREEN WOULD FLASH WHEN THIS WAS HAPPENING. THE CONNECTIONS WERE RE-SEATED SEVERAL TIMES WITH NO RESOLUTION. THE PHYSICIAN WANTED TO CONTINUE WITH THE PROCEDURE WITHOUT ANY FURTHER TROUBLESHOOTING. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18052171 ↗
• MalfunctionOct 18, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID BILATERAL FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE ON (B)(6) 2023, THE ACCURACY OF THE 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN) AND OF A 4.0MM ¿ STRAIGHT (0°) TRUDI NAVIGATION SHAVER BLADE (TSB4STR / LOT# UNKNOWN) WAS OFF BY ABOUT 4MM ON THE TRUDI NAVIGATION SYSTEM. NO TROUBLESHOOTING WAS PERFORMED. THE PROCEDURE CONTINUED WITHOUT RESOLUTION. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 13-OCT-2023, ADDITIONAL INFORMATION WAS RECEIVED RELATED TO THE 0° TRUDI NAV SUCTION DEVICE. PER THE ADDITIONAL INFORMATION, THE LOT NUMBER OF THE DEVICE CANNOT BE OBTAINED. WHEN THE ACCURACY ISSUE WAS OBSERVED, THE BAR BELOW THE DEVICE ICON ON THE TRUDI NAVIGATION SYSTEM MONITOR WAS GREEN. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAVIGATION MONITOR. THE SUCTION 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. THE CT SCAN CONTAINS ¿500+¿ SLICES. THE ACCURACY ISSUE WAS DETERMINED WHEN THE PHYSICIAN WAS PUTTING THE SUCTION DEVICE ON A CERT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962306 ↗
• InjuryJun 7, 2023Patient Device Interaction Problem; Patient Device Interaction 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 17084014 ↗
• MalfunctionApr 5, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  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 (TSB4STR / 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 (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT WHEN THE ACCURACY ISSUE WAS OBSERVED WITH THE TRUDI NAVIGATION SHAVER BLADE, 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 WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686688 ↗