Snowden-Pencer 32-5978Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403148606), received between Oct 21, 2021 and Oct 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2021Break; Break

  PER COMPLAINT DETAILS RECEIVED: CUSTOMER EXPLAINED THAT WHILE USING OUR KAYE-FREEMAN D-SEREDG SCISSR CVD 7IN (32-5978) IN SURGERY, A PORTION OF THE SCISSOR BROKE OFF INSIDE OF THE PATIENT. THEY THEN DID AN X-RAY AND COULD NOT FIND THE PORTION THAT BROKE OFF. IT STILL HAS NOT BEEN FOUND. 12OCT2021 ADDITIONAL INFORMATION: 1. WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED? PELVIC FLOOR RECONSTRUCTION. 2. DID ANY PART THE INSTRUMENT FALL INTO THE PATIENT¿S BODY, AND IF SO, HOW WAS IT RETRIEVED? YES, A SMALL PORTION OF A SCISSOR BLADE BROKE OFF FROM THE INSTRUMENT AND THE PIECE WAS NEVER FOUND. 3. WHAT WAS THE PATIENT¿S OUTCOME? PATIENT WAS STABLE AND UNAFFECTED. AN X-RAY WAS DONE, AND THE PIECE WAS NOT FOUND. 4. WAS THE PROCEDURE COMPLETED AS PLANNED? YES, THE PROCEDURE WAS COMPLETED AS PLANNED. 5. IS THE INSTRUMENT AVAILABLE TO SEND BACK TO US FOR AN EVALUATION? YES, THE INSTRUMENT IS AVAILABLE TO SEND BACK FOR EVALUATION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12671349 ↗