n.a. 27071ZJRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551079133), received between Feb 9, 2022 and Aug 12, 2024 — classified as 2 injuries, 1 malfunction.

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

• InjuryAug 12, 2024Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT THE FORCEPS BROKE WHILE PERFORMING A STONE REM. AFTER THE BREAKAGE THE FORCEPS COULD NO LONGER BE CLOSED AND THEREFORE COULD NOT BE REMOVED FROM THE BLADDER. THE CYSTOSCOPY HAD TO BE CONVERTED TO A LAPAROTOMY TO REMOVE THE BROKEN FORCEPS FROM THE BLADDER.

  Patient problems: Laceration(s)

  MAUDE report 19962753 ↗
• InjuryAug 12, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FORCEPS BROKE WHILE PERFORMING A STONE REM. AFTER THE BREAKAGE THE FORCEPS COULD NO LONGER BE CLOSED AND THEREFORE COULD NOT BE REMOVED FROM THE BLADDER. THE CYSTOSCOPY HAD TO BE CONVERTED TO A LAPAROTOMY TO REMOVE THE BROKEN FORCEPS FROM THE BLADDER.

  Patient problems: Laceration(s)

  MAUDE report 19962724 ↗
• MalfunctionFeb 9, 2022Break; Material Fragmentation; Material Twisted/Bent; Break; Material Fragmentation; Material Twisted/Bent

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(4): USER REPORTED THAT THE BIOPSY FORCEPS BROKE DURING SURGERY. THE CASE WAS A REMOVAL OF DJ STENT. 3FR GRASPER WAS REQUESTED BUT 3FR BIOPSY WAS OPENED. FUNCTIONAL CHECK WAS DONE BEFORE USING. IT BROKE AFTER INSERTION WHEN IT DID NOT HOLD ONTO ANYTHING YET. FLUSHED AND X-RAY DONE, HOWEVER, NO BROKEN PARTS WERE DETECTED. THERE COULD BE A POTENTIAL RISK OF A FOREIGN BODY LEFT IN THE PATIENT, BUT AT THIS POINT THERE IS NO INFORMATION THAT THERE HAS BEEN AN IMPACT TO THE PATIENT. SO, THERE IS NOT YET ENOUGH INFORMATION AVAILABLE TO CLASSIFY THE HEALTH IMPACT OR IF ANY OCCURRED. (MFR'S. INTERNAL COMPLAINT # (B)(4)).

  Patient problems: Insufficient Information

  MAUDE report 13497820 ↗