TruDi Curette TDC0005Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031465428), received between Jan 6, 2021 and Nov 6, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 18080761 ↗
• 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 18069818 ↗
• MalfunctionAug 3, 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 CURETTE (TDC0005 / LOT# UNKNOWN) WAS DISPLAYED ON THE TRUDI SYSTEM INACCURATELY ¿AND IN THE BRAIN.¿ IT WAS REPORTED THAT THE TRUDI CURETTE WAS DISPLAYING ON THE TRUDI SYSTEM ABOUT 4MM OFF IN COMPARISON TO THE SUCTION DEVICE THAT WAS PLACED IN THE SAME LOCATION. THE PROCEDURE WAS CONTINUED WITHOUT RESOLUTION. FIELD SERVICE ENGINEER (FSE) FOLLOW-UP WAS REQUESTED. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE LOT NUMBER OF THE TRUDI CURETTE IS NOT AVAILABLE. THE REPORTED ISSUE OCCURRED DURING THE TREATMENT OF THE FRONTAL AND ETHMOID SINUSES. WHEN THE ACCURACY ISSUE 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 FOR THE DEVICE. THE DEVICE WAS PLUGGED IN AFTER REGISTRATION. THE PATIENT TRACKER DID NOT MOVE AND THE TRACKER CABLE WAS NOT UNDER TENSION IN RELATION TO THIS EVENT. THE INFORMATION INDICATED THAT IT WAS ONE CT (COMPUTED TOMOGRAPHY) SCAN USED WITH ONE DEVICE. CT IMAGE WAS THE PRIMARY IMAGE USED; THE CT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17453583 ↗
• MalfunctionJun 23, 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 CURETTE (TDC0005 / LOT# UNKNOWN) WAS INACCURATE COMPARED TO THE TRUDI NAV SUCTION DEVICE. THE ENT CONSULTANT REPORTED THAT THE TRUDI CURETTE WAS PLUGGED INTO THE WHITE DONGLE, AND THE TRUDI NAV SUCTION DEVICE WAS PLUGGED INTO THE PURPLE DONGLE. IT WAS REPORTED THAT THEY HAD ISOLATED THE PROBLEM TO THE TRUDI CURETTE PLUGGED INTO THE WHITE DONGLE, VERSUS THE TRUDI NAV SUCTION DEVICE CONNECTED TO THE PURPLE DONGLE. THE PROCEDURE USING OTHER NAVIGATED INSTRUMENTS THAT WERE ACCURATE ON THE TRUDI NAVIGATION SYSTEM. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6)2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE LOT NUMBER OF THE TRUDI CURETTE IS NOT AVAILABLE. WHEN THE ACCURACY ISSUE WAS OBSERVED, THE DEVICE ICON ON THE TRUDI SYSTEM MONITOR WAS GREEN. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAV MONITOR. THE TRUDI CURETTE WAS PLUGGED IN AFTER REGISTRATION. RELATED TO WHETHER THE PATIENT TRACKER HAD MOVED OR IF THE PATIENT TRACKER CABLE WAS UNDER TENSION IN RELATION TO THE EVENT, THE RESPONSE RECEIVED WAS, ¿NO (AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195775 ↗
• MalfunctionJun 15, 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 CURETTE (TDC0005 / LOT# UNKNOWN) WAS INACCURATE COMPARED TO THE SUCTION OF THE CURETTE ON THE SAME ANATOMY. THE ENT CONSULTED REPORTED THAT IT WAS A 5-6MM DIFFERENCE. THE PROCEDURE WAS CONTINUED USING SUCTION ACCURACY. ON 30-MAY-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE DEVICE LOT NUMBER IS NOT AVAILABLE. WHEN THE ACCURACY ISSUE 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 FOR THE DEVICE. THE DEVICE WAS PLUGGED IN AFTER REGISTRATION. THE INFORMATION INDICATED THAT 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; NOT MORE THAN ONE CT SCAN WAS ATTEMPTED TO BE USED WITH ONE DEVICE. THE ENT CONSULTANT STATED THAT SHE BELIEVES THE CT SCAN CONTAINS MORE THAN 100 ¿ 158 SLICES. THE REPORTED INACCURACY WAS NOTICED WHEN THE CURETTE WAS ¿SHOWING FAR INTO THE BRAIN WHILE [THE] SURGEON WAS TOUCHING SK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140340 ↗
• InjuryNov 17, 2022Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STANDARD REVISION FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE ON (B)(6) 2022, THE FOLLOWING DEVICES WERE USED: TRUDI CURETTE (TDC0005 / LOT# UNKNOWN), 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT#: UNKNOWN), 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / LOT# UNKNOWN), A TRUDI PROBE (CATALOG / LOT# UNKNOWN), AND A CURVE SUCTION DEVICE (CATALOG / LOT# UNKNOWN). THERE WERE CONSTANT ACCURACY ISSUES ON THE TRUDI SYSTEM WITH ALL OF THE DEVICES ABOUT HALFWAY THROUGH THE PROCEDURE. THE DEVICES WERE RE-REGISTERED A FEW TIMES AND THE ISSUE WOULD TEMPORARILY BE RESOLVED, AND AS THE CASE PROCEEDED, THE ISSUE WOULD RECUR. IT WAS REPORTED THAT THE EMITTER PAD HAD MOVED SLIGHTLY AND THE PATIENT¿S HEAD HAD MOVED A FEW TIMES THROUGHOUT THE PROCEDURE; IT WAS NOTED THAT THE PATIENT WAS IN A REVERSE TRENDELENBURG AND ANGLED TO THE PHYSICIAN. THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED ON THE SAME DAY FOLLOWING THE PROCEDURE AND THE PATIENT WENT TO THE EMERGENCY ROOM (ER) ON 26-OCT-2022, DUE TO A CEREBROSPINAL FLUID (CSF) LEAK. INFORMATION RELATED TO THE PATIENT¿S SYMPTOMS AND H

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 15820418 ↗
• MalfunctionOct 18, 2021Material Fragmentation; Material Fragmentation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY HYBRID FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PERFORMED IN THE OPERATING ROOM ENVIRONMENT ON (B)(6) 2021, IT WAS REPORTED THAT WHEN THE SURGEON WAS BENDING THE TRUDI CURETTE (TDC0005 / 201023E-PC) USING THE BENDING TOOL, THE DISTAL END BROKE OFF. IT WAS CONFIRMED THAT THE DEVICE WAS OUTSIDE THE PATIENT¿S ANATOMY WHEN THE DISTAL TIP BROKE OFF. THIS WAS THE FIRST TIME THE DEVICE WAS PLACED IN THE BENDING TOOL; IT WAS NOT BENT PREVIOUSLY. THE DEVICE HAD NOT BEEN USED IN THE PATIENT. NOTHING UNUSUAL WAS NOTED ON THE DEVICE PRIOR TO USE. IT WAS PREPPED AND USED AS PER THE INSTRUCTIONS FOR USE (IFU). THE TRUDI CURETTE WAS EXCHANGED AND THE SURGEON COMPLETED THE CASE WITH THE REPLACEMENT DEVICE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12649283 ↗
• MalfunctionJan 6, 2021Fracture; Fracture

  THE HEALTHCARE PROFESSIONAL REPORTED THE PHYSICIAN BROKE THE TIP OF THE TRUDI CURETTE (TDC0005 / 201023E-PC) WHEN HE WAS BENDING IT OUTSIDE THE PATIENT¿S ANATOMY. THE PHYSICIAN NEVER USED THE TRUDI CURETTE IN THE PATIENT AFTER HE BROKE OFF THE TIP TRYING TO BEND IT WITH HIS FINGERS. THERE WAS NO PATIENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127984 ↗