BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1844927 · Received September 27, 2010

    Report

    Report Number
    3005075853-2010-05506
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 7, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RETURNED IN GOOD VISUAL CONDITION. 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 ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR INDEXED TWO TIMES DURING THE 12TH FIRING SEQUENCE THUS, IT OVER TRAVELED. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE CLIPS COULD NOT BE FED INTO THE JAWS. IN ORDER TO EVALUATE THE DEVICE'S INTERNAL COMPONENTS THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING OF THE DEVICE THE FEEDER SHOE WAS FOUND TO BE BENT; LEADING THE FOUND FEEDING ISSUES. FOURTEEN CLIPS WERE NOTED ON THE CLIP TRACK. A POSSIBLE CAUSE FOR THIS CONDITION MAY BE THAT THE DEVICE WAS FIRED WHEN A JAMMING HAVE OCCURRED. DUE TO THE RETURNED CONDITION OF THE DEVICE NO TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED OPENING ISSUES. BATCH # G9K19A, MFG DATE: 5/07/2010; EXP DATE: 4/07/2015. FEEDER SHOE. THE ANALYSIS RESULTS FOUND THAT DEVICE (C) WAS RETURNED IN GOOD VISUAL CONDITION. 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 ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT VISIBLE. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. BATCH # G9K62P, MFG DATE: 5/21/2010; EXP DATE: 4/21/2015. THE ANALYSIS RESULTS FOUND THAT DEVICE (D) WAS RECEIVED IN GOOD VISUAL CONDITION. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND THE LOCKOUT HAD BEEN FIRED THROUGH. PLEASE NOTE THE DEVICE CONTAINS A LOCKOUT FEATURE THAT IS DESIGNED TO INCREASE THE REQUIRED FORCE IT TAKES TO CLOSE THE TRIGGER ONCE THE LAST CLIP HAS BEEN FIRED; THIS REDUCES THE POSSIBILITY OF EMPTY JAWS BEING CLOSED ON A STRUCTURE. IN ADDITION, IF THE TRIGGER IS FORCED CLOSED ONCE THE LOCKOUT HAS BEEN ENGAGED, THE JAWS MAY REMAIN IN THE CLOSED POSITION. BATCH # G9K60L, MFG DATE: 5/21/2010; EXP DATE: 4/21/2015. DEVICE FIRED THROUGH LOCKOUT. THE BATCH RECORD WAS REVIEWED AND THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIP APPLIER JAMMED ON THE CYSTIC ARTERY ON FIRST FIRING. THE SURGEON ADVANCED THE CLIP AND PUT IT ACROSS THE ARTERY AND THEN COULDN`T GET IT OPEN. THEY HAD TO CUT THE DEVICE OUT, FIRST PLACING A CLIP CLOSER TO THE CYSTIC DUCT. THE NEXT TWO CLIP APPLIERS ALSO JAMMED OUTSIDE OF PATIENT BEFORE THEY WERE INTRODUCED INTO THE TROCAR. A FOURTH CLIP APPLIER WAS OPENED AND IT WORKED. SURGERY WAS PROLONGED 25 MINUTES. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. G4T62G

    Patients

    Seq Age Sex Outcome Treatment
    1