BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 3923037 · Received July 9, 2014

    Report

    Report Number
    3005075853-2014-04777
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 20, 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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS DEVICE STUCK ON TISSUE? --- NO. WAS USER EVER ABLE TO OPEN AND RELEASE DEVICE? --- NO, INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. IF SO, HOW WAS DEVICE OPENED? --- NA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE EL5ML DEVICE FOUND THAT IT WAS RECEIVED WITH A CONFORMING CLIP AND A MALFORMED CLIP JAMMED BETWEEN THE JAWS AND THE ADVANCER. THIS CONDITION PREVENTED THE DEVICE FROM PROPER FEEDING OF THE CLIPS. THE JAMMED CLIPS WERE REMOVED FROM THE DEVICE AND IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT; THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING, THE DEVICE LOCKED OUT AS INTENDED, HOWEVER THE ORANGE INDICATOR WAS NOTED UNDERTRAVELED. PLEASE NOTE THAT THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. PLEASE NOTE 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. 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 LAPAROSCOPIC CHOLECYSTECTOMY, THE JAWS BECAME NOT TO OPEN AFTER SEVERAL FIRINGS. THE DEVICE DID NOT CLAMP THE TARGET TISSUE AT THE TIME. 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
    399324 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1