BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 4203591 · Received October 27, 2014

    Report

    Report Number
    3005075853-2014-07389
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 8, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K913469
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS SHOWED THAT ONE EMS DEVICE WAS RETURNED NON-FUNCTIONAL. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS; THE RETURN SPRING WAS FOUND DISENGAGED FROM THE DRIVER LINK, AS A RESULT OF THE DRIVER LINK BEING BROKEN. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGED TO THE DRIVER LINK OCCURRED; IT SHOULD BE NOTED 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HERNIOPLASTY PROCEDURE, THE DEVICE WAS USED TO FIX THE HERNIA MESH AND DURING THE PROCEDURE THE SURGEON HEARD CRACKED NOISE IN HANDLE AND IT WAS NOT POSSIBLE TO FIRE THE STAPLES ANYMORE. IT SEEMS THAT THE SPRING IN THE HANDLE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. DELAY OF FIFTEEN MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682725 ENDOSCOPIC MULTIFEED STAPLER LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA K4DL3W

    Patients

    Seq Age Sex Outcome Treatment
    1