SHARK 8674225Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207056714), received between Oct 29, 2020 and Oct 29, 2020 — classified as 2 malfunctions.

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

• MalfunctionOct 29, 2020Break; Temperature Problem; Break; Temperature Problem

  ON FEBRUARY 4TH, 2021, RWMIC RECEIVED THE FOLLOWING INFORMATION FROM THE SALES REP: IN DISCUSSIONS WITH THE USER FACILITY AND THE DOCTOR IT WAS DETERMINED THAT IT WAS A MEDTRONIC GENERATOR CAUSING THE ISSUE. THE CUSTOMER WAS HAVING TO USE 3-4 LOOPS PER TURP. WE EXCHANGED OUT THE GENERATOR IN THE CYSTO ROOM AND FOUND IT WAS THE MEDTRONIC GENERATOR THAT WAS CAUSING THE LOOPS TO BURN OUT. THE CUSTOMER HAS SEND THE MEDTRONIC GENERATOR FOR REPAIR AND IS USING ONE OUT OF ANOTHER ROOM.

  Patient problems: Insufficient Information

  MAUDE report 10758869 ↗
• MalfunctionOct 29, 2020Break; Temperature Problem; Break; Temperature Problem

  ON OCTOBER 5TH , 2020, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): THE LOOPS WERE COMPLETELY BURNING OUT AND BREAKING DURING A TURP- WE WENT THROUGH 5 DIFFERENT LOOPS IN ONE CASE, AND IT ENDED UP CHARRING THE END OF THE SHEATH, WHICH LED TO BITS OF METAL BREAKING OFF INTO THE PATIENTS BODY. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? (ONLY APPLICABLE IF THERE WAS A REPORT OF DELAY) UNKNOWN. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

  Patient problems: Insufficient Information

  MAUDE report 10755385 ↗