TruClear 7209820Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521749948), received between Jul 20, 2020 and Jul 28, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (4 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 16, 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.

• MalfunctionJul 28, 2025Energy Output Problem; Appropriate Device Problem Term/Code Not Available; Energy Output Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PEDAL OF THE CONTROL UNIT STOPPED WORKING. TROUBLESHOOTING WAS DONE BUT IT REMAINED NOT WORKING. THE PROCEDURE HAD BEEN ABANDONED. THE PATIENT WAS AWARE OF THE INCIDENT AND WAS FINE THROUGHOUT THE PROCEDURE. THE PATIENT WAS ALSO AWAKE AND NOT UNDER ANESTHESIA WHEN THE ISSUE HAPPENED. THE SALES REPRESENTATIVE CAME BY THE NEXT DAY TO CHECK THE SYSTEM AND THE FOOTSWITCH WAS WORKING FINE. THERE WERE NO PROBLEMS REPORTED WITH THE FOOTSWITCH THEN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628080 ↗
• MalfunctionMar 3, 2025Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem; Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A HYSTEROSCOPY AND MYOMECTOMY PROCEDURE, THE DENSE TIS SHAVER PLUS EXPERIENCED A FAILURE OF THE WINDOW LOCK FEATURE AFTER INSERTING THE BLADE INTO THE BACK OF THE SCOPE WHEN IN THE UTERUS. THIS ISSUE LED TO UNANTICIPATED TISSUE LOSS. THE BLADE DID NOT COME PRE-WINDOW LOCKED, AND ATTEMPTS TO LOCK IT WITH THE FOOT PEDAL WERE UNSUCCESSFUL AS IT WOULD FALL OUT OF WINDOW LOCK DURING RESECTION. THERE WAS NO ISSUE WITH HANDPIECE. TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE, SUCTION WAS MANUALLY TURNED ON AND OFF TO ENSURE IT WAS ONLY ACTIVE DURING RESECTION. THE SURGEON CONTINUED TO USE THE DENSE TISSUE SHAVER (DTSP), ALTHOUGH THEY HAD TO MANUALLY TURN ON AND OFF THE SUCTION TO MAINTAIN DISTENTION A VISUALIZATION. NO ADDITIONAL OPERATION WAS PLANNED TO CORRECT THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 21503897 ↗
• MalfunctionFeb 7, 2025Energy Output Problem; Self-Activation or Keying; Communication or Transmission Problem; Fail-Safe Problem; Energy Output Problem; Self-Activation or Keying; Communication or Transmission Problem; Fail-Safe Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE WINDOW LOCK BUTTON INCREASED THE SPEED ON THE CONTROL UNIT INSTEAD OF LOCKING THE SOFT TISSUE SHAVER. THEY USED A DIFFERENT FOOTSWITCH AND THE WINDOW LOCK BUTTON, AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21338373 ↗
• 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 DID NOT 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 RE-OPERATION 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 15639468 ↗
• InjuryFeb 10, 2022Energy Output Problem; Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem; Energy Output Problem; Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem

  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 13510490 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE START OF THE PROCEDURE, WHEN RUNNING A DENSE TISSUE SHAVER PLUS DEVICE ON THE HANDPIECE WITH A SCOPE AND A TISSUE SHAVER, IT JAMMED AND FAILED TO ROTATE. SWITCHED HANDPIECES AND BLADES AND AGAIN EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS CANCELLED, THEN RESCHEDULED AND COMPLETED USING ANOTHER EQUIPMENT. PATIENT WAS UNDER ANAESTHESIA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13489337 ↗
• MalfunctionJul 20, 2020Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Energy Output Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING POLYPECTOMY, THE DEVICE HAD A MALFUNCTION THAT LEAD TO THE PROCEDURE BEING ABORTED. THE PATIENT WAS NOT ANESTHETIZED AND THE RE-SCHEDULED PROCEDURE WAS SUCCESSFUL.

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

  MAUDE report 10299424 ↗