BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX

    MDR report key: 3483015 · Received November 20, 2013

    Report

    Report Number
    3483015
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Date of Event
    November 13, 2013
    Report Date
    November 20, 2013
    Manufacturer
    ETHICON ENDO-SUGERY, LLC
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A LAP CHOLE. THE CLIP APPLIER WOULD NOT FIRE PROPERLY. ANOTHER DEVICE WAS OBTAINED AND THE CASE CONTINUED WITHOUT INCIDENT. NO PATIENT HARM.====================== MANUFACTURER RESPONSE FOR ENDOSCOPIC CLIP APPLIER, LIGAMAX ENDOSCOPIC MULTIPLE CLIP APPLIER (PER SITE REPORTER).====================== REPORTER NOT AWARE OF SALES REP RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601644 LIGAMAX STAPLE, IMPLANTABLE FZP ETHICON ENDO-SUGERY, LLC * K4DF72

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR