BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 3013147 · Received March 20, 2013

    Report

    Report Number
    3005075853-2013-01321
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME 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). THE DEVICE WAS RECEIVED WITH THE ELECTRODE SEPARATED FROM THE CERAMIC AND THE ELECTRODE IS STILL ATTACHED TO THE ACTIVE ROD. THE CERAMIC IS DAMAGED AND PARTIALLY MISSING. THE CERAMIC WAS DAMAGED BY THE SEPARATION OF THE ELECTRODE FROM THE LOWER JAW. TESTING FOUND A SHORT ON THE DEVICE WHEN THE JAWS ARE FULLY OR PARTIALLY CLOSED, RESULTING IN THE "REPOSITION JAWS AND REACTIVE" YELLOW MESSAGE SCREEN IS ADVISING THAT THE INSTRUMENT IS BEING ACTIVATED ON LOW IMPEDANCE (THIN) TISSUE OR METAL (SUCH AS STAPLES, CLIPS, RETRACTORS, OR CLAMPS). THIS ERROR SCREEN CAN ALSO BE A RESULT OF THE ELECTRODE SHORTING WITH THE UPPER JAW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE ELECTRODE SEPARATED FROM THE JAW DURING USE. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116504 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK J4C22L

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR