TruDi Shaver Blade TSB415Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031469297), received between Nov 3, 2023 and Jan 27, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 18070186 ↗