BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSEAL

    MDR report key: 2982488 · Received February 28, 2013

    Report

    Report Number
    3005075853-2013-00907
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 14, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4): ADDED ADDITIONAL INFORMATION THE DEVICE WAS RECEIVED WITH THE ELECTRODE SEPARATED BUT IS STILL ATTACHED TO THE ACTIVE ROD AND THE CABLE CUT OFF. FUNCTIONAL TESTING CAN NOT BE PERFORMED DUE TO AN INSTRUMENT WITH CABLE CUT OFF WAS RECEIVED. THE INSTRUMENT BLADE WAS INSPECTED AND WAS FOUND CONFORMING. WITH THE EXCEPTION OF THE ELECTRODE SEPARATION THE JAW WAS NOT BROKEN. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLECTOMY PROCEDURE, THE BLADE APPEARED TO BE BROKEN. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87043 NSEAL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE