BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 3800271 · Received May 8, 2014

    Report

    Report Number
    3005075853-2014-03127
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 16, 2014
    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

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND LOCKED OUT. THE INSTRUMENT IS DESIGNED TO LOCK OUT AFTER ALL THE CLIPS HAVE BEEN FIRED. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLING. UPON DISASSEMBLING, MASSIVE DRIED BODY FLUIDS WERE FOUND INSIDE THE HANDLES AND SHAFT SUBASSEMBLY. PLEASE NOTE THAT ACCUMULATION OF BODY FLUIDS IS COMMON DURING SURGICAL PROCEDURES AND DOES NOT NECESSARILY INDICATE A MANUFACTURING DEFECT IN THE DEVICE. IN ADDITION, 2 CONFORMING CLIPS, 4 GAP CLIPS, 4 MALFORMED CLIPS AND 2 PEAR SHAPED CLIPS INSIDE A SAMPLE BAG WERE RECEIVED. IT IS POSSIBLE THAT DUE TO THE ACCUMULATION OF MASSIVE DRIED BODY FLUIDS THE CLIPS WERE NOT PROPERLY FED INTO THE JAWS CAUSING THE CLIPS NOT TO FORM AS INTENDED. HOWEVER, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CLIPS WERE MALFORMED THOUGH THE DEVICE WAS FIRED SEVERAL TIMES. SOME CLIPS WERE TEARDROP-SHAPED AND OTHERS WERE UNFORMED. 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
    277126 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4DE6U

    Patients

    Seq Age Sex Outcome Treatment
    1