BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM

    MDR report key: 5544442 · Received April 4, 2016

    Report

    Report Number
    3005075853-2016-01861
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Date of Event
    February 3, 2016
    Report Date
    February 3, 2016
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. BATCH # = M93638. THE ANALYSIS RESULTS OF THE EL5ML DEVICE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED AND IT FED AND FORMED 10 CLIPS AS INTENDED, THE NEXT CYCLE RESULTED IN NO CLIP FED AND FINALLY IT FED AND FORMED TWO MALFORMED CLIPS. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS THE DEVICE WAS DISASSEMBLED; UPON DISASSEMBLING THE FEEDBAR WAS FOUND DAMAGED CAUSING THE INTERMITTENT FEEDING ISSUE. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE DAMAGE ON THE FEEDBAR. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, ON THE FIRST FIRING OF THE DEVICE, THE CLIP WOULD NOT RELEASE OUT OF THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202175 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA M4J75M

    Patients

    Seq Age Sex Outcome Treatment
    1