BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX 5MM ENDO CLIP APPLIER

    MDR report key: 6108122 · Received November 16, 2016

    Report

    Report Number
    3005075853-2016-06580
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 31, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE SURGEON LOADING THE CLIP AND INSPECTING THE CLIP IN THE JAWS OFF OF THE VESSEL PRIOR TO PLACING THE CLIP ON THE VESSEL: THEY COME PRE-LOADED; CAN MORE INFORMATION BE SHARED REGARDING CLIP SHAPE OR FORM: NO; WHAT DID THE SURGEON DO TO ADDRESS THE INADEQUATE CLIP FORMATION IN THE INITIAL SURGICAL PROCEDURE: GET ANOTHER ONE; WERE CLIPS APPLIED FROM BOTH OF THE DEVICES USED IN THE PROCEDURE: YES; IN THE RE-OP WERE THE CLIPS STILL SECURE ON THE VESSEL: NO; HOW WAS THE BILE DUCT LEAK ADDRESSED: ERCP PROCEDURE & PERC DRAIN PUT IN; IF THERE WAS AN ADDITIONAL SURGICAL PROCEDURE, COULD THE CLIP BE IDENTIFIED AT SURGICAL SITE: WERE THEY FULLY FORMED? NO OTHER SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON REPORTED THAT THE CLIPS SEEMED TO BE FALLING OFF, OR NOT FULLY CLOSED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS BROUGHT BACK DUE TO A BILE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759144 LIGAMAX 5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA N4LT8X

    Patients

    Seq Age Sex Outcome Treatment
    1