BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 3231498 · Received July 17, 2013

    Report

    Report Number
    3005075853-2013-03591
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072493
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS RECEIVED WITH THE ELECTRODE DETACHED FROM INSTRUMENT AND NOT RETURNED.THE CERAMIC IS FRACTURED AND PARTIALLY MISSING. THE CERAMIC WAS DAMAGED BY THE SEPARATION OF THE ELECTRODE FROM THE LOWER JAW.VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED AND EVIDENCE OF ACTIVE ROAD WAS NOTED.BECAUSE OF THE MISSING ELECTRODE WE WERE UNABLE TO TEST THE FULL FUNCTIONALITY OF THE INSTRUMENT.IT IS POSSIBLE THAT A REPLACE INSTRUMENT WAS NOTED DURING USAGE WITH THE JAW DAMAGED IN THIS MANNER. THIS WAS NOT CONFIRMED DURING COMPLAINT ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS REVERSION, THE ELECTRODE FELL OFF INTO THE PATIENT AND HAD TO BE RETRIEVED. THERE WAS NO REPORTED PATIENT IMPACT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332214 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR