MalfunctionGEI
POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION
Received Jul 31, 2026 · Event occurred Jul 9, 2026
Report 3011050570-2026-00773 · MDR key 50099094
Device
Generic name
Powerseal 5mm, 37cm, Curved Jaw Sealer & Divider, Double-action
Manufacturer
Gyrus Acmi, Inc.Model number
PS-0537CJDAProduct problems
- Unintended System Motion
- Activation Failure
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The customer reported cutting trigger did not operate, but the blade extended automatically and performed a cut during an unspecified therapeutic procedure involving an Olympus Powerseal. There was no patient injury reported.
Additional Manufacturer Narrative
The investigation is ongoing. A supplemental report will be submitted when the investigation is completed or if additional information becomes available.