BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX

    MDR report key: 1374873 · Received February 25, 2009

    Report

    Report Number
    3005075853-2009-01204
    Event Type
    Malfunction
    Date Received
    February 25, 2009
    Date of Event
    January 26, 2009
    Report Date
    January 26, 2009
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT A: JAW/CAM. INSTRUMENT B: EXP DATE: 10/2013; 11/27/2008; JAW/CAM. INSTRUMENT C: EX DATE: 10/2013; MFR DATE: 11/13/2008; INDICATOR. INSTRUMENT D: ADVANCER. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE A WAS RECEIVED WITH ONE JAW AND CAM RAMP DISENGAGED. THE DEVICE WAS CYCLED AND EJECTED THE REMAINING CLIPS DUE THE CONDITION OF THE JAW. POSSIBLE CAUSES FOR THIS CONDITION MAY BE INADVERTENT FORCE, TWISTING OR PRESSURE BEING PLACED ON THE DEVICE JAWS, USING THE JAWS OF THE DEVICE AS A DISSECTOR/RETRACTOR OR DAMAGE TO THE JAWS WHILE ENTERING THE TROCAR. ADDITIONALLY THE ORANGE INDICATOR WAS NOTED BEYOND ITS INTENDED POSITION. THE ANALYSIS RESULTS FOUND THAT THE DEVICE B WAS RECEIVED WITH THE JAW AND CAM RAMP DISENGAGED. THIS CONDITION WOULD NOT ALLOW THE JAWS TO COLLAPSE IN ORDER TO FORM THE CLIP. POSSIBLE CAUSES FOR THIS CONDITION MAY BE INADVERTENT FORCE, TWISTING OR PRESSURE BEING PLACED ON THE DEVICE JAWS, USING THE JAWS OF THE DEVICE AS A DISSECTOR/RETRACTOR OR DAMAGE TO THE JAWS WHILE ENTERING THE TROCAR. THE ANALYSIS RESULTS CONFIRMED THAT ONE EL5ML DEVICE C WAS RECEIVED IN GOOD VISUAL CONDITION. THE DEVICE WAS CYCLED, FED AND FORMED THE REMAINING FIVE CLIPS WITHIN MANUFACTURING SPECIFICATIONS. THE DEVICE LOCKED OUT AS INTENDED, BUT THE ORANGE INDICATOR WAS NOTED BEYOND ITS INTENDED POSITION. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE D WAS RETURNED WITH THE JAWS IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS; FOUR MALFORMED CLIPS WERE RELEASED. THE ADVANCER WAS NOTED TO BE BROKEN DURING EVALUATION. THE DEVICE WAS CYCLED AND MALFORMED THE REMAINING SEVEN CLIPS DUE TO THE ADVANCER CONDITION. A POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE IS LOADING A CLIP IN THE JAWS, TO ENSURE THAT THE DEMARCATION BETWEEN THE JAWS AND THE DEVICE SHAFT IS PAST THE END OF THE TROCAR CANNULA. ADDITIONALLY, EXCESSIVELY APPLYING A SIDE LOAD TO THE JAWS, CAUSING THEM TO PARTIALLY COLLAPSE COULD RESULT IN A CLIP MALFORMATION. THE DEVICE JAWS SHOULD BE FULLY OPEN AND PARALLEL UPON INITIATING THE FIRING OF THE DEVICE. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. 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 LAP CHOLECYSTECTOMY PROCEDURE, TWO DEVICES KEPT JAMMING THE CLIP ON TOP OF EACH OTHER. TWO OTHER DEVICES WERE EJECTING CLIPS FROM THE JAWS OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX FZP, CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC NA E4MG1J

    Patients

    Seq Age Sex Outcome Treatment
    1