BEUDAMED
    FDA Enforcement Class II Ongoing

    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, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA

    Recall: Z-1700-2024 · Reported May 8, 2024

    Enforcement

    Recall Number
    Z-1700-2024
    Event ID
    94375
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 8, 2024
    Initiation Date
    March 7, 2024
    Classification Date
    April 30, 2024
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    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, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA

    Reason

    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.

    Code Info

    UDI-DI: 00821925044555 Lot numbers: CA182543, CA182544, CA182546, CA182548, CA191230

    Distribution

    Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.

    Quantity

    850 units: (400 units US);(450 units OUS)