BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENICON A-LI-GATOR CLIP APPLIER

    MDR report key: 10504873 · Received September 8, 2020

    Report

    Report Number
    3002590791-2020-00103
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    July 12, 2018
    Report Date
    September 8, 2020
    Manufacturer
    GENICON, INC.
    Product Code
    GDO
    UDI-DI
    00877972006343
    PMA / PMN Number
    K030269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A REVIEW OF COMPLAINT FILES BETWEEN (B)(6) 2017 THROUGH (B)(6) 2019.

    Description of Event or Problem · 1

    DURING A LAP CHOLE WHEN SURGEON TRIED TO FIRE CLIP THE CLIPS JAMMED AND NO CLIPS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970020 GENICON A-LI-GATOR CLIP APPLIER CLIP APPLIER GDO GENICON, INC. 360-010-001 I9718-A 00877972006343

    Patients

    Seq Age Sex Outcome Treatment
    1