BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1831711 · Received January 4, 2008

    Report

    Report Number
    1527736-2008-00096
    Event Type
    Malfunction
    Date Received
    January 4, 2008
    Date of Event
    December 19, 2007
    Report Date
    December 20, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, WHEN THE SURGEON FIRED THE DEVICE, THE CLIPS DID NOT STAY ON TISSUE SECURELY. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH THE SAME DEVICE. THERE WAS NO PATIENT CONSEQUENCE. NO RETURN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1