TruDi Shaver BladeRecalls & reported problems across all models

We found 3 models of TruDi Shaver Blade by Acclarent, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Apr 5, 2023 and Sep 11, 2025 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (11 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. 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

Most reported TruDi Shaver Blade problems

TruDi Shaver Blade models

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

• TruDi Shaver Blade TSB4STR

  Ear, Nose, and Throat Stereotaxic Instrument
  16 reports
• TruDi Shaver Blade TSB415

  Ear, Nose, and Throat Stereotaxic Instrument
  7 reports
• TruDi Shaver Blade TSB460

  Ear, Nose, and Throat Stereotaxic Instrument
  1 report

Recent TruDi Shaver Blade adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJan 27, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY PROCEDURE, 10 SECONDS AFTER CONNECTING THE 4.0MM ¿ 15° TRUDI NAVIGATION SHAVER BLADE (TSB415 / 241015B-PC), THE LOGO FOR THE DEVICE STARTED FLICKERING IN AND OUT ON THE TRUDI NAVIGATION SYSTEM. THE SHAVER BLADE WAS SWITCHED TO A DIFFERENT PORT, BUT THE SAME ISSUE OCCURRED. IT WAS THEN SWITCHED BACK TO THE ORIGINAL PORT AND THE DEVICE WAS NOT RECOGNIZED AT ALL ON THE TRUDI NAVIGATION SYSTEM. THE SHAVER BLADE WAS REPLACED, AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 26-JAN-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE SERIAL NUMBER MARKED ON THE TRUDI CONNECTOR (USB) IS NOT READILY AVAILABLE. THE SOFTWARE VERSION USED IS THE ¿NEWEST VERSION WE HAVE OUT. NOT SURE WHAT THAT IS, [VERSION] 2.3.2.3?¿ THERE WAS NO ERROR MESSAGE DISPLAYED ON THE TRUDI NAV MONITOR FOR THE DEVICE WHEN THE ISSUE OCCURRED. FLICKER HAPPENED AND THE DONGLES WERE SWITCHED BUT STILL HAPPENED, BUT NEW ERROR POPPED UP. WHEN THE ISSUE OCCURRED, DONGLES 3 AND 5 WERE IN USE; BOTH WERE WHITE DONGLES. THE SHAVER BLADE MODE WAS INTENDED TO BE IN CONTINUOUS MODE. THE INF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242889 ↗
• 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 ↗
• 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 19177532 ↗
• 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 19102181 ↗
• InjuryMar 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ENT ((EAR, NOSE & THROAT ) PROCEDURE WITH WITH ACCLARENT DEVICE: TRUDI SHAVER BLADE 4.0MM - 15° CURVED - 5PK EXPERIENCED CSF LEAK (CEREBROSPINAL FLUID LEAKAGE). IT WAS ALSO REPORTED THAT THE PATIENT EXHIBITED NO SYMPTOMS RELATED TO THE ADVERSE EVENT, THE ONLY DEVICE USED TO DISCOVER AND CONFIRM THE EVENT WAS AN ENDOSCOPE. IT WAS ALSO NOTED THAT THE PHYSICIAN NEEDED TO PATCH THE PATIENT WITH A GRAFT OF THE PATIENT'S TISSUE, THE PATIENT REQUIRED OVERNIGHT OBSERVATION AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 18887843 ↗
• 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 ↗
• MalfunctionFeb 15, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE MOST POSTERIOR BLADE OF A TRUDI SHAVER BLADE 4.0MM - 15° CURVED - 5PK (TSB415, 230905A-PC) WAS FLICKERING IN AND OUT. NON ACCLARENT DEVICES WERE NOT USED. THERE WAS NO ALLEGATION THAT A DEATH OR SERIOUS INJURY OCCURRED DUE TO THE USE OF THE PRODUCT. A WHITE DONGLE WAS USED WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712885 ↗
• MalfunctionFeb 12, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON 01-FEB-2024, DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, WHEN THE 4.0MM ¿ 15° TRUDI NAVIGATION SHAVER BLADE (TSB415Z / LOT# UNKNOWN) WAS TRACKING ON THE TRUDI NAVIGATION SYSTEM (FG200000 / S/N: (B)(6), SOFTWARE VERSION 2.3.2, ¿IT WOULD JUMP TO SHOW THE STANDARD CT SCAN THEN IT WOULD JUMP TO SHOW LIKE IT WAS TRACKING AGAIN.¿ THE CONNECTIONS FOR THE TRUDI SHAVER BLADE WAS RESEATED AGAIN WITH NO RESOLUTION. IT WAS REPORTED THAT THEY WERE ABLE TO CONTINUE THE PROCEDURE USING THE TRUDI SHAVER BLADE. THE DEVICE IS NOT AVAILABLE FOR RETURN. IT WAS ALSO REPORTED THAT THE TRUDI NAVIGATION SYSTEM DISPLAYED AN ERROR (CODE UNKNOWN) THAT INDICATED THAT THE 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / 2112140) NEEDED TO BE REPLACED. THE BAR BELOW THE DEVICE ICON ON THE TRUDI SYSTEM MONITOR WAS RED. THE 0° TRUDI NAV SUCTION DEVICE WAS REPLACED AND THE ISSUE RESOLVED. THE DEVICE IS NOT AVAILABLE FOR RETURN. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. ON 09-FEB-2024, LIMITED ADDITIONAL INFORMATION WAS RECEIVED PERTAINING ONLY TO THE TRUDI SHAVER BLADE. PER THE ADDITIONAL INFORMATION RECEIVED, THE LOT NUMBER OF THE TRUDI SH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691419 ↗

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