BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3223857 · Received July 12, 2013

    Report

    Report Number
    3005075853-2013-03539
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 4, 2013
    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
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE 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 5 CONFORMING CLIPS AND THEN, ONE JAW/CAM RAMP GOT DISENGAGED CAUSING THE LAST CLIP TO BE EJECTED. THE DEVICE LOCKED OUT AS INTENDED; HOWEVER, THE ORANGE INDICATOR OVER TRAVELED. POTENTIAL CAUSES FOR THE REPORTED INCIDENT COULD BE NOT FULLY SQUEEZING THE DEVICE TRIGGER CAUSING PARTIALLY FORMED CLIPS; OR FIRING THE INSTRUMENT WITH THE JAWS NOT COMPLETELY OPEN CAUSING DAMAGED CLIP OR FEEDING MECHANISM. HOWEVER, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. PLEASE NOTE THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE 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 5 CONFORMING CLIPS AND THEN, ONE JAW/CAM RAMP GOT DISENGAGED CAUSING THE LAST CLIP TO BE EJECTED. THE DEVICE LOCKED OUT AS INTENDED; HOWEVER, THE ORANGE INDICATOR OVER TRAVELED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE EVENT REPORTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A "LAPAROSCOPIC GALLE" PROCEDURE, THE SURGEON LOADED THE DEVICE TWO TIMES AND RELEASED - NO CLIPS. THE THIRD CLIP APPLIED BUT DIDN'T HOLD. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE HAS BEEN RETAINED AT FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321784 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4CT8Y

    Patients

    Seq Age Sex Outcome Treatment
    1