BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 726441 · Received June 13, 2006

    Report

    Report Number
    1527736-2006-02693
    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
    GA, US
    Reporter Occupation
    OTHER

    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 CHOLECYSTECTOMY PROCEDURE ON THE 13TH FIRING A PIECE OF THE CAM CAME OFF OF PRODUCT AND FELL INTO PT. THE PIECE WAS RETRIEVED. WAS ABLE TO COMPLETE PROCEDURE W/DEVICE. DEVICE USED UNDER NORMAL APPLICATION, NOT PERFORMING CHOLANGIOGRAPHY. 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 C4DP3X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN