BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*MCA MED APPLIER

    MDR report key: 12264325 · Received August 2, 2021

    Report

    Report Number
    3005075853-2021-04349
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    June 22, 2021
    Report Date
    July 8, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    UDI-DI
    10705036002475
    PMA / PMN Number
    K820837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: UNKNOWN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NECK DISSECTION PROCEDURE, THE CLIPS WERE FIRED BUT REMAINED OPEN ('KEGS" WERE NOT CLIPPED). CLIPS ALSO EJECTED. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157791 LIGACLIP*MCA MED APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. MCM20 U40T7U 10705036002475

    Patients

    Seq Age Sex Outcome Treatment
    1