BEUDAMED
    FDA Enforcement Class II Ongoing

    Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B

    Recall: Z-1988-2023 · Reported June 28, 2023

    Enforcement

    Recall Number
    Z-1988-2023
    Event ID
    92325
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 28, 2023
    Initiation Date
    May 4, 2023
    Classification Date
    June 21, 2023
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B

    Reason

    Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.

    Code Info

    UDI-DI: 04953170385926 Lot Numbers: 24K, 26K, 27K, 29K, 2XK, 2YK

    Distribution

    US Nationwide distribution.

    Quantity

    45 pieces