BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM CLIP APPLIER

    MDR report key: 1810046 · Received November 12, 2007

    Report

    Report Number
    1527736-2007-07528
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 10, 2007
    Report Date
    October 24, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LAP CHOLECYSTECTOMY PROCEDURE, THE CLIPS DID NOT CLOSE ALL THE WAY. USED A NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP APPLIER FZP ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4J907

    Patients

    Seq Age Sex Outcome Treatment
    1