BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON MULTI CLIP APPLIER LIGA CLIP MEDIUM CL

    MDR report key: 2139622 · Received June 16, 2011

    Report

    Report Number
    2134070-2011-00008
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ETHICON
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THAT A LIGACLIP (MULTI-CLIP APPLIER DEVICE) SEVERED A VESSEL WHEN IT WAS APPLIED DURING A PROCEDURE. NO NEGATIVE PT OUTCOMES HAVE BEEN REPORTED BY THE PT OR USER FACILITY DUE TO THIS EVENT. STERILMED, INC HAS CONTACTED THE USER FACILITY FOR ADDITIONAL INFO AND ALSO TO RETRIEVE THE DEVICE IN QUESTION. THUS FAR THE USER FACILITY HAS NOT COMPLIED WITH THE DEVICE RETURN REQUESTS. THEREFORE STERILMED, INC HAS BEEN UNABLE TO PERFORM A QUALITY INVESTIGATION ON THE SUSPECT DEVICE. STERILMED, INC WILL SUBMIT ADDITIONAL INFO TO FDA PERTAINING TO THIS EVENT IF IT BECOMES AVAILABLE. THESE DEVICES ARE RIGOROUSLY TESTED PRIOR TO SHIPMENT TO THE CUSTOMER THEREFORE DECREASING THE LIKELIHOOD FOR A DEVICE FAILURE. HISTORIC OCCURRENCES OF THIS TYPE OF EVENT ARE INFREQUENT. THE FACT THE DEVICE WAS REPROCESSED IN NO WAY MADE IT MORE SUSCEPTIBLE FOR AN EVENT LIKE THIS TO OCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LIGACLIP SEVERED A VESSEL WHEN APPLIED DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON MULTI CLIP APPLIER LIGA CLIP MEDIUM CL LIGA CLIP NMJ ETHICON ETHMCM20

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention