Olympus PS-0544CJSARecalls & reported problems
Gyrus ACMI, LLC · POWERSEAL 5 MM, 44 CM, CURVED JAW SEALER & DIVIDER, SINGLE-ACTION (5/PK) · Class 2
All models of Olympus (27)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925044982), received between Jun 10, 2026 and Jun 10, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation Failure” (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
- Activation Failure1
Patient problems
- Alteration in Body Temperature1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2026Activation Failure
IT WAS REPORTED THE POWERSEAL CURVED JAW SEALER HAD NO ACTIVATION FROM THESE DEVICE. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.
Patient problems: Alteration in Body Temperature; No Clinical Signs, Symptoms or Conditions
MAUDE report 25460697 ↗
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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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