Olympus PS-0537SJDARecalls & reported problems
Gyrus ACMI, LLC · POWERSEAL 5 MM, 37 CM, STRAIGHT JAW SEALER & DIVIDER, DOUBLE-ACTION (5/PK) · Class 2
All models of Olympus (27)
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 00821925045033), received between Sep 19, 2025 and Sep 19, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Key or Button Unresponsive/not Working” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Key or Button Unresponsive/not Working2
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.
MalfunctionSep 19, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE POWERSEAL DEVICE'S COAG BUTTON WAS NOT CLICKING. THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23096868 ↗MalfunctionSep 19, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23096861 ↗
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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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