BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM

    MDR report key: 5766145 · Received July 1, 2016

    Report

    Report Number
    3005075853-2016-03724
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    June 10, 2016
    Report Date
    June 10, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED WITH NO DAMAGE IN THE EXTERNAL COMPONENTS. IN ADDITION, 3 BROKEN PIECES OF CLIPS WERE RECEIVED IN A PLASTIC BAG. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED AND FORMED 5 CLIPS AS INTENDED. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. DURING FUNCTIONAL TESTING NO MALFORMED CLIPS WERE NOTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 07/26/2016. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED WITH NO DAMAGE IN THE EXTERNAL COMPONENTS. IN ADDITION, 3 BROKEN PIECES OF CLIPS WERE RECEIVED IN A PLASTIC BAG. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED AND FORMED 5 CLIPS AS INTENDED. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. DURING FUNCTIONAL TESTING NO MALFORMED CLIPS WERE NOTED. IN ADDITION, THE RETURNED PIECES WERE INSPECTED AND THEY WERE FOUND DISCOLORED, MOST LIKELY DUE TO BEING IN CONTACT WITH AN ENERGIZED DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DOCTOR PLACES THREE CLIPS ON THE CYSTIC DUCT SIDE AND ONE CLIP ON THE CYSTIC GALL BLADDER SIDE. WHILE TRANSECTING THE DUCT WITH THE HARH36, HE NOTICED THAT A CLIP THAT WAS ON THE DUCT HAD FRAGMENTED. HE IDENTIFIED THE PIECES AND REMOVED ALL OF THEM. BECAUSE OF THIS, THEY OPENED ANOTHER DEVICE AND COMPLETED THE CASE WITH NO PATIENT ADVERSE EVENTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419582 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA N4LK0E

    Patients

    Seq Age Sex Outcome Treatment
    1