TRUCLEARTM Handpiece 7209807Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010501943), received between Jul 20, 2020 and Jun 19, 2024 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 19571027 ↗
• InjuryFeb 22, 2022Fail-Safe Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Fail-Safe Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING AN OPERATIVE HYSTEROSCOPY, HYSTEROSCOPIC MYOMECTOMY PROCEDURE, THE BLADE OF THE DEVICE WOULD NOT MOVE WHEN WINDOW LOCK PRESSED ON FOOTSWITCH. WINDOW LOCK DID NOT FUNCTION AND TEST BLADE RAN AT EXCEEDINGLY FAST SPEEDS. THE PATIENT WAS UNABLE TO BE TREATED AND WAS RESCHEDULED.

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

  MAUDE report 13578466 ↗
• InjuryFeb 10, 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 13510484 ↗
• InjuryFeb 10, 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 13510478 ↗
• InjuryFeb 10, 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 13510467 ↗
• InjuryFeb 10, 2022Fail-Safe Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Fail-Safe Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BLADE OF THE DEVICE WOULD NOT MOVE WHEN THE WINDOW LOCK PRESSED ON FOOTSWITCH. THE WINDOW LOCK DID NOT FUNCTION AND THE TEST BLADE RAN AT EXCEEDINGLY FAST SPEEDS. THE PATIENT WAS UNABLE TO BE TREATED AND WAS RESCHEDULED.

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

  MAUDE report 13510451 ↗
• InjuryFeb 8, 2022Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Mechanical Jam; 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 13489177 ↗
• MalfunctionJul 20, 2020Break; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Break; Mechanical Jam; 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: No Code Available

  MAUDE report 10299469 ↗
• MalfunctionJul 20, 2020Fail-Safe Problem; Adverse Event Without Identified Device or Use Problem; Fail-Safe 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: No Code Available

  MAUDE report 10299462 ↗