Snowden-Pencer SP8341Recalls & reported problems
Steris Corporation · FLAT NOSE ERGONOMIC MODULAR 5MM,36CM,ESU INSERT · Class 2
All models of Snowden-Pencer (62)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403171710), received between Oct 8, 2025 and Nov 20, 2025 — classified as 2 malfunctions.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 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 THE TIP OF THEIR FLAT NOSE DISSECTOR BROKE. 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 23610647 ↗MalfunctionOct 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THE TIP TO THEIR FLAT NOSE DISSECTOR INSERT DETACHED DURING A PATIENT PROCEDURE. EMPLOYEE RECEIVED MEDICAL TREATMENT (X-RAYS) FOLLOWING THE REPORTED EVENT. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23247294 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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