BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1831396 · Received December 17, 2007

    Report

    Report Number
    1527736-2007-08552
    Event Type
    Malfunction
    Date Received
    December 17, 2007
    Date of Event
    December 4, 2007
    Report Date
    December 6, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP. COLON PROCEDURE, ON THE SEVENTH FIRING, THE DEVICE WAS UNABLE TO BE OPENED. AFTER MANIPULATION, THE DEVICE FINALLY OPENED UP. THEY USED ANOTHER LIKE DEVICE TO COMPLETE WITH NO PT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1