BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 726433 · Received June 13, 2006

    Report

    Report Number
    1527736-2006-02696
    Event Type
    Malfunction
    Date Received
    June 13, 2006
    Date of Event
    May 22, 2006
    Report Date
    May 22, 2006
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    FZP
    PMA / PMN Number
    k050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 510(K) NUMBER IS K050344.

    Description of Event or Problem · 1

    DURING A LAP CHOLE PROCEDURE, THE JAWS SPLIT OR FELL OFF THE TRACK. DID NOT FORM ANY KIND OF CLIP. THIS OCCURRED ON THE 4TH FIRING CYCLE. DEVICE WAS BEING FIRED OVER TISSUE. SURGEON PERFORMED A CHOLANGIOGRAM AFTER NEW DEVICE WAS OPENED. CASE COMPLETED WITH ANOTHER DEVICE. NO PT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN