TRUCLEARTM Control Unit 7209808Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010501929), received between Feb 10, 2022 and Jul 24, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Intermittent Energy Output” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2023Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY MYOMECTOMY, THE HANDPIECE AND BLADE JUST STOPPED WORKING AND CONTROL UNIT SAID "STA LLED MOTOR, TRY NEW HANDPIECE". THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. HAND TO SWITCH OUT HANDPIECES AND BLADES AND CASE WAS ABORTED AFTER TWO BLADES AND TWO HANDPIECES WERE ATTEMPTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17386366 ↗
• InjuryApr 13, 2023Connection Problem; Appropriate Device Problem Term/Code Not Available; Connection Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY, THE HANDPIECE PORT ON THE CONTROL UNIT WAS NOT ACCEPTING THE HANDPIECE PLUG. THE HANDPIECE WAS UNABLE TO BE PLUGGED IN TO PERFORM THE PROCEDURE. CASE WAS ABORTED, RESCHEDULE AND THERE BE AN ADDITIONAL OPERATION TO BE PERFORMED TO CORRECT THE ISSUE. THE PATIENT WAS UNDER ANESTHESIA BEFORE DISCOVERING THAT THE CONTROL UNIT WAS DEFECTIVE. ANOTHER CONTROL UNIT WAS TESTED AND IT WORKED FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16737314 ↗
• InjuryFeb 10, 2022Fail-Safe Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Fail-Safe Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A 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 13510454 ↗