BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1970877 · Received January 26, 2011

    Report

    Report Number
    3005075853-2011-00310
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 30, 2010
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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; ONE PEAR SHAPED CLIP WAS RELEASED. FURTHER EVALUATION FOUND THAT THE DEVICE WAS EMPTY AND THE LOCKOUT MECHANISM WAS ACTIVATED. A POSSIBLE CAUSE OF THE INCIDENT REPORTED MAY BE THAT A BYPASS OF THE ADVANCER 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. IN ADDITION, AN INVESTIGATION WAS INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF JAW OPENING ISSUES. DURING THIS INVESTIGATION ADVANCER BYPASS WAS IDENTIFIED AS ONE POTENTIAL ROOT CAUSE; THEREFORE, ADVANCER BYPASS IS BEING EVALUATED IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE MADE AN UNUSUAL SOUND ON THE SECOND FIRING AND THE CLIP WAS MALFORMED. HE REMOVED THE MALFORMED CLIP. HE THEN FIRED IT OUTSIDE OF THE PATIENT AND IT FIRED FINE, SO HE REINTRODUCED THE DEVICE INTO THE SURGICAL FIELD AND TRIED TO FIRE IT AGAIN AND IT LOCKED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4U327

    Patients

    Seq Age Sex Outcome Treatment
    1