TruClear 7209807Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521749924), received between May 11, 2018 and Sep 28, 2026 — classified as 5 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926382 ↗
• MalfunctionFeb 3, 2026Mechanical Jam; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A HYSTEROSCOPY POLYPECTOMY, THE SOFT TISSUE SHAVER WAS NOT DISSECTING PROPERLY, APPEARED SLOW AND SEEMED BLUNT. THE DENSE TISSUE SHAVER PLUS WAS THEN USED, BUT THE SITUATION DID NOT IMPROVE. A REUSABLE HAND INSTRUMENT WAS ALSO TRIED, RESULTING IN ONLY A VERY SLIGHT IMPROVEMENT. THE POLYP BEING REMOVED WAS OVER 3 CM IN SIZE. DUE TO THE PERFORMANCE OF THE DEVICES, THE PROCEDURE HAD TO BE COMPLETED USING BIPOLAR RESECTION, WHICH WAS NOT INITIALLY AVAILABLE IN THE HOSPITAL. THIS SWITCH EXTENDED THE SURGICAL TIME BY ONE HOUR.

  Patient problems: Insufficient Information

  MAUDE report 24244629 ↗
• MalfunctionMar 24, 2025Break; Overheating of Device; Self-Activation or Keying; Mechanical Jam; Break; Overheating of Device; Self-Activation or Keying; Mechanical Jam

  IT WAS REPORTED THAT PRIOR TO USE, THE TRUCLEAR CONTROL UNIT BEGAN TO MALFUNCTION, WITH SMOKE ESCAPING THROUGH THE VENT ON THE RIGHT SIDE OF THE CONTROL UNIT. UPON ACTIVATING THE FOOT PEDAL, THE BLADE WOULD NOT WINDOW LOCK OR ACTIVATE. ADDITIONALLY, THE HANDPIECE BEGAN TO MALFUNCTION, BECAME HOT, AND THE INNER MECHANISM STARTED MOVING WITHOUT ACTIVATION OF THE FOOT PEDAL. THE TRUCLEAR CONTROL UNIT DISPLAYED ERROR CODE 10 DURING SURGERY AND UPON TESTING IT WAS READING ERROR 6. THE CONTROL UNIT WAS TESTED WITH 11 OTHER WORKING HANDPIECES AND STILL WAS NOT WORKING AND WAS SHOWING E6 ERROR CODE. FOOTSWITCH AND BLADE FUNCTIONED PROPERLY ON OTHER WORKING CONTROL UNITS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679026 ↗
• MalfunctionOct 28, 2024Failure to Cut; Appropriate Device Problem Term/Code Not Available; Failure to Cut; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING PROCEDURE, UPON SHAVER INSERTION AND ACTIVATION OF THE FOOT PEDAL, THE BLADE ROTATED BUT DID NOT R ESECT/SHAVE. USED ANOTHER SHAVER BUT IT FAILED TOO. THE PROCEDURE WAS ABORTED.

  Patient problems: Insufficient Information

  MAUDE report 20551399 ↗
• MalfunctionOct 17, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE PLASTIC RING ON THE END OF THE HANDPIECE CONNECTOR WAS BROKEN. THIS CAUSED THE SOCKET ON THE CONSOLE THAT IT PLUGS INTO TO BREAK. THE OPERATION HAD TO BE CANCELLED DUE TO FAULTY DEVICE. ALTERNATIVE SETS USED AND THEY HAVE PROVIDED ADDITIONAL EQUIPMENT.

  Patient problems: Insufficient Information

  MAUDE report 20471757 ↗
• InjuryJun 19, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A POLYPECTOMY PROCEDURE, THE NURSE TRIED TO ATTACHED THE FIRST HANDPIECE TO THE CONTROL UNIT, BUT IT WOULD NOT ATTACH. TRIED WITH ANOTHER ONE BUT IT ALSO WOULD NOT ATTACH. THE OUTER RING FROM THE SHAFT OF THE HANDPIECES HAS COME OFF AND ONE OF THESE WAS STILL IN THE CONTROL UNIT. THERE WAS NO PATIENT INJURY, HOWEVER, PROCEDURE WAS NOT COMPLETED AND HAD TO BE ABANDONED. AND AN ADDITIONAL OPERATION WAS PERFORMED TO CORRECT THE ISSUE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571026 ↗
• MalfunctionAug 2, 2023Break; Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem; Break; Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE MOTOR OF THE DEVICE STALLED AND THE DEVICE WOULD NOT WINDOW LOCK. THERE WAS NO MOVEMENT WHEN PLUGGED INTO CONSOLE AND PEDAL PRESSED, OR WHEN WINDOW LOCK BUTTON. THE PROCEDURE JUST HAD TO BE STOPPED AS THEY WERE UNABLE TO REMOVE THE PATHOLOGY. THE HANDPIECE HAD TO BE CHANGED FOR ANOTHER HANDPIECE, SO THE PROCEDURE COULD CONTINUE. THE PATIENT REQUIRES FURTHER TREATMENT DUE TO FAILURE OF THE DEVICE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446373 ↗
• MalfunctionMay 12, 2023Fire; Material Integrity Problem; Fire; Material Integrity Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD SLITS IN THE CORD TO THE UNIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924429 ↗
• InjuryOct 27, 2022Suction Problem; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Suction Problem; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING POLYPECTOMY AND MORCELLATION FOR A HYSTERECTOMY, THE SUCTION LEVER ON THE HANDPIECE WAS JAMMED IN THE OFF POSITION WHEN THE SURGEON WENT TO ACTIVATE THE SHAVER. THE PATHOLOGY WAS MORCELLATED BUT NO SPECIMEN WAS ASPIRATED INTO TISSUE TRAP AND VISION WAS COMPROMISED DUE TO NO SUCTION. THIS DELAYED THE PROCEDURE FOR MORE THAN 30 MINUTES WHILE THEY TRIED TO TROUBLESHOOT THE ISSUE EVENTUALLY RESULTING IN A SECOND SET BEING OPENED TO USE AN ALTERNATIVE TRUCLEAR HANDPIECE. WITH USE OF THE SECOND HANDPIECE THE SPECIMEN WAS CAPTURED IN THE TISSUE TRAP. THERMAL ABLATION, WHICH WAS A SUBSEQUENT PLANNED PROCEDURE FOR THIS PATIENT WAS CANCELLED DUE TO EXTENDED RUN TIME OF SURGERY. THE PROCEDURE WAS COMPLETED WITH NO UNPLANNED MEDICAL INTERVENTION PERFORMED DUE TO THE EVENT. THERE WAS AN UNANTICIPATED TISSUE LOSS DUE TO NON-ASPIRATION SO A BIOPSY OF THAT PARTICULAR AREA WAS NOT PERFORMED AFTER IT WAS MORCELLATED. NO REPORTS OF ANY PATIENT ISSUES POST OPERATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15681077 ↗
• InjuryOct 20, 2022Difficult or Delayed Activation; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Activation; Mechanical Jam; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPIC ENDOMETRIAL POLYPECTOMY, WHEN THE FOOT PEDAL WAS STEPPED ON TO SHAVE A POLYP, THE SHAVER DOESN'T MOVE AT HIGH SPEED AS USUAL, AND IT FELT LIKE IT WAS GETTING STUCK AND SO THEY STOPPED. THE POWER WAS TURNED OFF AND RESTARTED AFTER ABOUT 30 SECONDS; THIS TIME, THE SAME MOVEMENT OCCURRED EVEN WHEN THE WINDOW LOCK BUTTON WAS PRESSED, AND EVEN WHEN THE FOOT PEDAL WAS PRESSED, IT WAS THE SAME AS BEFORE. SHAVING THE POLYP A LITTLE BIT AS IS WAS ATTEMPTED, BUT IT COULD NOT BE SHAVED AS EXPECTED. THE POWER WAS TURNED OFF AND RESTARTED AGAIN, BUT IT DID NOT IMPROVE JUST LIKE THE SITUATION ABOVE. IT WAS DETERMINED THAT THE OPERATION COULD NOT BE CONTINUED; THE OPERATION WAS PERFORMED MIDWAY, BUT THE OPERATION WAS DISCONTINUED AND A REOPERATION WAS SCHEDULED FOR ANOTHER DAY. THEY HAVE ALSO POSTPONED TOMORROW'S OPERATION BECAUSE THE REPLACEMENT MACHINE WILL NOT ARRIVE IN TIME. IT WAS POSSIBLE THAT THE OTHER ASSOCIATED DEVICES SUCH AS CONTROL UNIT, FOOT SWITCH AND HANDPIECE WAS DEFECTIVE/PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15640183 ↗
• MalfunctionJun 3, 2022Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, THE DEVICE METAL SHAVING WAS STUCK.

  Patient problems: Insufficient Information

  MAUDE report 14594645 ↗
• MalfunctionMar 23, 2022Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, THE DEVICE STOPPED WORKING. THERE WAS PATIENT INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13866729 ↗
• InjuryFeb 8, 2022Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A PROCEDURE INSIDE THE UTERINE CAVITY PRIOR TO MYOMECTOMY, THEY WENT TO PERFORM WINDOW LOCK, BUT DID NOT FUNCTION. THE DEVICE WAS THEN REMOVED FROM THE UTERINE CAVITY AND FURTHER COMPLICATIONS IN RELATION TO DEVICES NOT WORKING WERE EXPERIENCED. THEY HAVE TESTED ONE HANDPIECE AND IT WAS RUNNING EXCEEDINGLY FAST, SO FAST THAT IT SEIZES THE TEST BLADE. IT RAN AT 3500 RPM THEN STOPPED. THEY'VE TRIED A SECOND HANDPIECE AND AGAIN IT WAS RUNNING AT SPEEDS IN EXCESS OF WHAT IS DISPLAYED ON THE CONTROL UNIT, ABOUT 1000 RPM OVER. THEY CHANGED HANDPIECE AND BLADE AND EXPERIENCED THE SAME ISSUE. THEY WERE USING A DENSE TISSUE SHAVER PLUS. IT WAS NOTED THAT THE DENSE TISSUE SHAVER PLUS DEVICE JAMMED ON ALL HANDPIECES WHEN THE DEVICE HAD BEEN RUNNING FOR OVER 1MIN AT 2500 RPM. THE CASE WAS CANCELLED. THEY WERE UNABLE TO TREAT THE PATIENT AND WAS RESCHEDULED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13488391 ↗
• MalfunctionJul 28, 2021Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE METAL WAS PEELING OFF, WHITE IN COLOR INSIDE THE HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12238397 ↗
• InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER CERVICAL POLYP REMOVAL, THE PATIENT HAD LARGE ARTERIAL HEMORRHAGE FOR MORE THAN 500 CC. THERE WERE NO PROBLEMS DURING THE SURGERY AND THE SURGERY WAS COMPLETED, BUT THE ISSUE OCCURRED THE NEXT MORNING. THERE WERE NO PRODUCT ABNORMALITIES DURING THE SURGERY AND NO TISSUE DAMAGE, BUT THE BLEEDING POINTS WERE ENTERED INTO THE CERVICAL CANAL FROM THE MAIN PART OF THE LEFT CERVICAL ARTERY VIA THE ASCENDING BRANCH. AROUND AREA SCRAPED BY THE SHAVER NEAR THE INTERNAL CERVICAL OS. TREATMENT WAS ATTEMPTED BY SECURING A BALLOON ETC., BUT WAS NOT EFFECTIVE AT ALL. HEMOSTASIS WAS PERFORMED VIA UTERINE ARTERY EMBOLIZATION (UAE) TREATMENT IN THE EVENING. NO TRANSFUSION OF BLOOD. PATIENT WAS NOT ON ANY MEDICATION, NO ACTIVE BLEEDING AFTER THE PATIENT WAS DISCHARGE FROM THE OPERATING ROOM AND D & C WAS NOT PERFORMED AFTER THE DEVICE WAS USED. PATIENT HAD NO PROBLEM AFTER HEMOSTASIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11543584 ↗
• MalfunctionJul 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY, WHEN THEY UNATTACHED THE TUBING TO THE METAL PORT, THE ENTIRE PORT CAME OUT OF THE HAND PIECE LIKE THE METAL BROKE. THE METAL SUCTION PART FELL OFF. NO PARTS FELL INTO THE PATIENT CAVITY AND THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10285851 ↗
• MalfunctionApr 5, 2020Contamination; Material Fragmentation; Contamination; Material Fragmentation

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD SHAVED ON INSIDE AND RUSTY AS SEEN WITH BOROSCOPE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9927137 ↗
• MalfunctionJan 6, 2020Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING INSPECTION OF STERILE PROCESSING DEPARTMENT (SPD), THE DEVICE HAD A MANUFACTURING DEFECT REFLECTED ON THE INSIDE WORKING CANNULA. THE INTERNAL LUMEN IS EXPERIENCING SHEDDING ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9553383 ↗
• MalfunctionNov 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SET-UP, A PIECE OF THE DEVICE CHIPPED.

  Patient problems: No Information

  MAUDE report 9269135 ↗
• MalfunctionOct 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE BACK OF THE SHAVER HANDPIECE THAT COLLECTS TISSUE CAME OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Information

  MAUDE report 9195060 ↗
• MalfunctionApr 9, 2019Mechanical Jam; Mechanical Jam

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SHAVER WAS LOCKING UP. DILATION AND CURETTAGE WAS DONE TO COMPLETE THE CASE. NO PATIENT HARM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8497180 ↗
• MalfunctionMay 22, 2018Break; Defective Component; Break; Defective Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CONNECTOR TO THE MACHINE BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7534359 ↗
• MalfunctionMay 18, 2018Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE WAS FOR GOING OFF PROGRAM, THE SWITCHER LEVEL IN THE UNIT WAS GETTING STUCK AND IT WAS HARD TO TURN IT ON AND OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7527092 ↗
• MalfunctionMay 16, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING TESTING, THE HANDLE CRACKED. NO FURTHER INFORMATION AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7519031 ↗
• MalfunctionMay 16, 2018Break; Defective Component; Break; Defective Component

  ACCORDING TO THE REPORTER, DURING TESTING, THE DEVICE¿S PLUG WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7518634 ↗