BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A LI-GATOR

    MDR report key: 10250256 · Received July 9, 2020

    Report

    Report Number
    3002590791-2020-00031
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    January 12, 2018
    Report Date
    July 8, 2020
    Manufacturer
    GENICON, INC.
    Product Code
    GDO
    PMA / PMN Number
    K030269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A REVIEW OF COMPLAINT FILES RECEIVED BETWEEN (B)(6) 2017 AND (B)(6) 2019. THE DIMENSION BETWEEN THE STEEL DISC, WHICH IS USED FOR PRESSING STAPLES, AND THE CARTRIDGE'S COVERING PLATE DID NOT MATCH WELL, WHICH CAUSED THE STAPLE STUCK PROBLEM. A REPAIR TO THE TOOLING OF THE STEEL DISC WAS COMPLETED AND PROBLEM RESOLVED.

    Description of Event or Problem · 1

    LIGATION CLIPS WERE SHOOTING OUT OF THE JAWS OF THE CLIP APPLIER DURING A LAP CHOLE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719692 A LI-GATOR SINGLE-USE LAPAROSCOPIC CLIP APPLIER GDO GENICON, INC. 360-010-001 I8252

    Patients

    Seq Age Sex Outcome Treatment
    1