Snowden-Pencer SP8344Recalls & reported problems
Steris Corporation · DEBAKEY ERGONOMIC MODULAR 5MM,36CM,35MM JAW,ESU INSERT · Class 2
All models of Snowden-Pencer (62)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403171741), 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bowel Perforation1
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# SP8344, LOT# UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT PATIENT INJURED DURING TRIAL OF PRODUCT, NO BD PRODUCT MALFUNCTIONED. VERBATIM: PATIENT INJURY WHEN TRIALING ON 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. ON 01MAR2023 ADDITIONAL INFORMATION: PATIENT HAD A FOLLOW UP SURGERY AT ANOTHER FACILITY WITH PARTIAL RESECTION TO REPAIR DAMAGE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Bowel Perforation
MAUDE report 16525005 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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