FDA recall Z-1699-2024

Olympus Corporation of the Americas · Class II · device

Product

POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0523CJDA

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.

Key facts

Status
Ongoing
Initiation date
2024-03-07
Report date
2024-05-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1699-2024