BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 726438 · Received June 13, 2006

    Report

    Report Number
    1527736-2006-02694
    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
    FL, 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

    THERE WERE THREE DEVICES THAT STOPPED WORKING DURING A LAP CHOLECYSTECTOMY PROCEDURE. WITH THE FIRST DEVICE, AFTER 2 TO 3 FIRINGS, A PIECE OF THE METAL JAWS CAME OFF INSIDE THE PT. THE PIECE WAS REMOVED WITH GRASPERS WITHOUT DIFFICULTY. THIS DEVICE HAD BEEN FIRED OVER A CATHETER DURING A CHOLANGIOGRAPHY AT THE BEGINNING OF THE CASE AND OTHERWISE WAS FIRED UNDER NORMAL CONDITIONS. THE SECOND DEVICE WAS USED AND AFTER 2 OR 3 CLIPS WERE FIRED, THEY SQUEEZED THE HANDLE AND THE JAWS WOULD NOT CLOSE. THIS DEVICE HAD BEEN USED UNDER NORMAL FIRING CONDITIONS. A THIRD DEVICE WAS PULLED AND IT FIRED A FEW CLIPS AND THEN THE JAWS WOULD TURN CROOKED. THIS DEVICE WAS FIRED UNDER NORMAL CONDITIONS. THEY OPENED A FOURTH DEVICE AND COMPLETED THE CASE WITH NO PT CONSEQUENCES.

    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