BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 3122773 · Received May 21, 2013

    Report

    Report Number
    3005075853-2013-02474
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 1, 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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED WITH THE ELECTRODE SEPARATED BUT IS STILL ATTACHED TO THE ACTIVE ROD AND THE CABLE CUT OFF. FUNCTIONAL TESTING CANNOT BE PERFORMED DUE TO AN INSTRUMENT WITH CABLE CUT OFF WAS RECEIVED. IT IS POSSIBLE THAT A REPLACE INSTRUMENT WAS NOTED DURING USAGE WITH THE ELECTRODE DAMAGED IN THIS MANNER. THIS WAS NOT CONFIRMED DURING COMPLAINT ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE THE DEVICE GAVE AN ALERT SCREEN TO ¿REPOSITION JAWS AND REACTIVATE¿. THEY CONTINUED TO GET THE ERROR AND THEN A SECOND LIKE DEVICE WAS USED. WHEN THE SURGEON OBSERVED THE DEVICE THE ELECTRODE WAS SEPARATED FROM THE JAW. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223828 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK J4CT7F

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR