BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX

    MDR report key: 3476837 · Received November 14, 2013

    Report

    Report Number
    3476837
    Event Type
    Malfunction
    Date Received
    November 14, 2013
    Date of Event
    November 13, 2013
    Report Date
    November 14, 2013
    Manufacturer
    ETHICON ENDO-SUGERY, LLC
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS DOING A LAP CHOLE AND USED AN ENDOSCOPIC MULTIPLE CLIP APPLIER. THE CLIP APPLIER WOULD NOT FIRE PROPERLY. ANOTHER CLIP APPLIER OPENED AND WORKED WITHOUT INCIDENT.====================== MANUFACTURER RESPONSE FOR ENDOSCOPIC CLIP APPLIER, LIGAMAX ENDOSCOPIC MULTIPLE CLIP APPLIER (PER SITE REPORTER).====================== SALES REP WANTS TO PICK THE DEVICE UP AND SEND IN FOR EVALUATION. SALES REP NOTIFIED BY CHARGE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591148 LIGAMAX APPLIER, SURGICAL, CLIP FZP ETHICON ENDO-SUGERY, LLC * K4DF72

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR