BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM

    MDR report key: 4220732 · Received November 3, 2014

    Report

    Report Number
    3005075853-2014-07568
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    September 22, 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
    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 FIRING OF THE DEVICE, TWO UNFORMED CLIPS WERE FED DUE TO A FAILURE OF THE ANTI-BACKUP FEATURE; ON THE NEXT ACTUATIONS, THREE CONFORMING CLIPS WERE FED. IN ADDITION, THE LOCKOUT MECHANISM WAS FOUND TO BE NON-FUNCTIONAL AND THE ORANGE INDICATOR WHEEL OVERTRAVELED. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS THE INSTRUMENT WAS DISASSEMBLED. UPON DISASSEMBLING, THE RATCHET PAWL WAS FOUND TO BE DAMAGED, CAUSING THE FAILURE OF THE ANTI-BACKUP AND LOCKOUT MECHANISM. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. 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 SIGMA PROCEDURE, CLIP WASN´T FIRED. CLIPS CLAMPED IN THE DEVICE. A NEW DEVICE WAS OPENED, SAME PROBLEM. NO FURTHER INFORMATION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701823 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4EU7F

    Patients

    Seq Age Sex Outcome Treatment
    1