BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 3133777 · Received May 29, 2013

    Report

    Report Number
    3005075853-2013-02621
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 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
    HK
    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. THE DEVICE WAS RECEIVED WITH THE ELECTRODE SEPARATED FROM THE CERAMIC AND THE ELECTRODE IS STILL ATTACHED TO THE ACTIVE ROD. THE CERAMIC WAS CRACKED BUT IS STILL BONDED TO 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). THEN THE "REPLACE INSTRUMENT" SCREEN WOULD BE DISPLAYED AFTER RECEIVING THE "REPOSITION AND REACTIVATE" MESSAGE TWICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE THE ELECTRODE ON THE LOWER JAW WAS DETACHED DURING THE SURGERY. WHEN THEY COAGULATE THE LOCAL BLEEDER AND ACTIVATE ON THE SAME SITE FOR MORE THAN A FEW SECONDS, WHEN THEY PULL AWAY THE JAW, THE ELECTRODE WAS DETACHED. IT CANNOT BE USED AS ERROR APPEARED ON THE GENERATOR. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235593 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK J4CU7U

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR