BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 2971817 · Received February 21, 2013

    Report

    Report Number
    3005075853-2013-00781
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. MULTIPLE REQUEST FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS DIDN'T PROPERLY FORM. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76334 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1