BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX- CLIP APPLIER

    MDR report key: 2120211 · Received June 10, 2011

    Report

    Report Number
    3005075853-2011-02356
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 15, 2011
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH JAWS IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED; TWO PEAR SHAPED CLIPS WERE RELEASED. A POSSIBLE CAUSE OF THIS CONDITION MAY BE THAT AN ADVANCER BYPASS HAPPENED. THIS CAN OCCUR WHEN THE TIP OF THE ADVANCER IS ABOVE OR BELOW THE CLIP INSTEAD OF BEING POSITIONED AT THE BACK OF THE CLIP, SINCE THE CLIP IS NOT FULLY ADVANCED IN THE JAWS. THIS WILL PREVENT THE JAWS FROM CLOSING PROPERLY, RESULTING IN A PEAR SHAPED CLIP AND SUBSEQUENTLY THE JAWS MAY REMAIN CLOSED AFTER FIRING, REQUIRING A MANUAL TRIGGER OPENING. UPON FIRING, THE TIP OF THE ADVANCER SLID TOWARD TISSUE STOP CAUSING THAT THE JAWS REMAINED IN THE CLOSED. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED; A PEAR SHAPED CLIP WAS RELEASED. A DESIGN CHANGE WAS IMPLEMENTED TO MINIMIZE THE OCCURRENCE OF THIS ISSUE. THE REMAINING CLIPS WERE FED AND PROPERLY FORMED. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT VISIBLE. PLEASE NOTE THAT THIS CONDITION IS UNRELATED WITH THE INCIDENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE TRIGGER BECAME NOT TO BE GRASPED AFTER A FEW FIRINGS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1