Olympus Corporation of the Americas: POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal,

Hazard

Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.

Details from the source

Reason for recall: Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery. Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR. Quantity: 850 units: (400 units US);(450 units OUS) Lot/code info: UDI-DI: 00821925044555 Lot numbers: CA182543, CA182544, CA182546, CA182548, CA191230

UPC codes

00821925044555

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.