BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP CLIP APPLIER - SMALL - 19 CM

    MDR report key: 1182587 · Received October 3, 2008

    Report

    Report Number
    1527736-2008-03685
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Report Date
    May 14, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/12/2008. THE ANALYSIS RESULTS CONFIRMED THAT THE INSTRUMENT WAS RETURNED WITH SIGNS OF WEAR, BUT WAS OTHERWISE IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS LOADED, RETAINED, AND FORMED THE CLIPS PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. WHILE WE WERE UNABLE TO RECREATE THE EVENT, WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIPS WERE NOT HOLDING AND GRASPING TISSUE. THE CLIPS APPEARED TO BE SCISSORED. A SECOND DEVICE WAS USED TO COMPLETE THE CASE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP CLIP APPLIER - SMALL - 19 CM NONE LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1