BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 4093491 · Received September 16, 2014

    Report

    Report Number
    3005075853-2014-06446
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 14, 2014
    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 SEPARATED FROM THE CERAMIC BUT STILL ATTACHED TO THE ACTIVE ROD. THE DEVICE WAS VISUALLY INSPECTED AND THERE WERE NO DAMAGE OBSERVED TO THE IBLADE AND TO THE JAW AS REPORTED IN THE EVENT DESCRIPTION. UPON VISUAL INSPECTION UNDER MAGNIFICATION IT WAS NOTED THAT THE CERAMIC WAS 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 AN ALERT SCREEN "REPOSITION JAWS AND REACTIVE". THIS IS ADVISING THAT THE INSTRUMENT IS BEING ACTIVATED ON LOW IMPEDANCE (THIN) TISSUE OR METAL (SUCH AS STAPLES, CLIPS, RETRACTORS, OR CLAMPS). THE "REPLACE INSTRUMENT" ALERT SCREEN WOULD BE DISPLAYED AFTER RECEIVING THE "REPOSITION AND REACTIVATE" OR " ALERT SCREEN TWICE. THE SEPARATED ELECTRODE PREVENTED THE INSTRUMENT FROM FULLY CYCLING OPEN OR CLOSE. THIS IS DUE THE INTERFERENCE BETWEEN THE BLADE AND ELECTRODE. THERE IS INSUFFICIENT EVIDENCE RELATED TO WHAT CAUSED THE DAMAGE ON THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS PROCEDURE, THE SURGEON WENT OVER A SUTURE WITH THE DEVICE AND THE IBLADE CAME OUT OF THE JAW AND FELL INTO THE PATIENT. THE DEVICE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571149 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA L90Y7F

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR