Snowden-Pencer SP8343Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403171734), received between Mar 10, 2023 and Mar 10, 2023 — classified as 1 injury.

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.

• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MAT# SP8343 LOT# UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT PATIENT INJURED DURING TRIAL OF PRODUCT, NO BD PRODUCT MALFUNCTIONED. VERBATIM: PATIENT INJURY WHEN TRIALING. 21FEB2023 ADDITIONAL INFORMATION: 1. WHAT WAS THE OPERATION/PROCEDURE THAT WAS BEING PERFORMED? THE CASE WAS A SMALL BOWEL OBSTRUCTION. 2. WHAT WAS THE OUTCOME/INJURY TO THE PATIENT? SMALL PUNCTURE TO THE BOWEL. 3. WHICH PART OF THE DEVICE MALFUNCTIONED OR WAS FAULTY, I.E. SP94, SP83, SP8343? NONE OF THE PRODUCTS (SP94, SP83, SP8343) MALFUNCTIONED. 4. WHEN WAS THE DEFECT FOUND? BEFORE USE, DURING USE, OR AFTER USE? THERE IS NOT A DEFECT. 5. WHAT ARE THE LOT NUMBERS FOR THESE DEVICES? UNSURE AT THIS TIME. 6. CAN YOU PLEASE SEND ALL PARTS OF THE INSTRUMENT FOR EVALUATION? YES. 7. DO YOU HAVE PHOTOS OF THE REPORTED ISSUE ON THE INSTRUMENT? NO ISSUE TO INSTRUMENT. IN REGARDS TO THIS CASE, I JUST WANT TO ELABORATE SLIGHTLY. THERE WAS NO MALFUNCTION OF OUR INSTRUMENT THAT CAUSED THIS INJURY. NO BENDS OR SCREWS POPPING OFF OR ANYTHING LIKE THAT. 01MAR2023 ADDITIONAL INFORMATION: PATIENT HAD A FOLLOW UP SURGERY AT ANOTHER FACILITY WITH PARTIAL RESECTION TO REPAIR DAMAGE.

  Patient problems: Bowel Perforation

  MAUDE report 16526188 ↗