Snowden-Pencer SP90-6343Recalls & reported problems
Steris Corporation · DIAMOND-LINE CLAMP DEBAKEY, 25MM JAW 5MM, 36CM, RATCHETED ESU PAT PENDING · Class 2
All models of Snowden-Pencer (62)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403159268), received between May 3, 2021 and Nov 20, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2025Break; Break
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR DEBAKEY CLAMP BROKE AT THE TIP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23610659 ↗MalfunctionJun 1, 2023Break; Break
MAT# SP90-6343 LOT# UNKNOWN. VERBATIM: THE JAW OF THE GRASPER BROKE WHILE BEING USED IN SURGERY. THEY HAD TO BRING X-RAY IN TO ENSURE NOTHING FELL INSIDE THE PATIENT. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 17039293 ↗MalfunctionMay 3, 2021Break; Break
GRASPER STOPPED WORKING CORRECTLY DURING A CASE AND IT WAS LATER OBSERVED THAT THE SCREW BROKE OFF OF THE DEVICE. IT WAS REMOVED AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. X-RAY SHOWED THAT A PIECE OF THE SCREW WAS STILL INSIDE THE PATIENT'S ABDOMEN AND WOULD NEED TO BE SURGICALLY REMOVED AFTER THE PATIENT RECOVERED.
Patient problems: Foreign Body In Patient
MAUDE report 11762838 ↗
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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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