BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1970879 · Received January 26, 2011

    Report

    Report Number
    3005075853-2011-00312
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    November 8, 2010
    Report Date
    January 3, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). OPENING ISSUES. THE DEVICE 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. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. IN ORDER TO CONFIRM THE CLIPS WERE WITHIN MANUFACTURING SPECIFICATIONS, THE CLIPS WERE EVALUATED USING A TOOL THAT IS DESIGNED TO DETERMINE PROPER FORMATION. A POSSIBLE CAUSE OF THE FOUND CONDITION OF THE JAWS 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; HOWEVER, THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS MAY RESULT IN CLIP MALFORMATION. THE APPLICATION OF TORQUE CREATES A TEMPORARY MISALIGNMENT OF THE TIPS WHICH IS KNOWN TO PRODUCE A SCISSORED CLIP. PLEASE NOTE THAT COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. AT THIS TIME, THERE IS NO OBSERVABLE TREND RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS WERE DELIVERED MALFORMED, THEY WERE CROSSED AT THE EXIT OF THE APPLIER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4TX92

    Patients

    Seq Age Sex Outcome Treatment
    1