BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 4090173 · Received September 15, 2014

    Report

    Report Number
    3005075853-2014-06420
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 7, 2014
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE UPPER JAW DETACHED AND RETURNED. UPON VISUAL INSPECTION IT WAS NOTED THAT THE RETENTION PIN WERE SHEARED OFF AND PRESENT INSIDE THE JAW. THE DEVICE WAS CONNECTED TO THE GENERATOR AND IT WAS RECOGNIZED. BECAUSE THE JAW WAS DETACHED NOT ALL FUNCTIONAL TESTING COULD BE PERFORMED WITH THE GENERATOR. A PROBABLE CAUSE OF THE DAMAGE TO THE JAW COULD BE NOT ALLOWING THICK AND FIBROUS TISSUES TO DENATURE PRIOR TO I-BLADE ADVANCEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRECTOMY, THE JAW WAS BROKEN OFF WHEN THE DEVICE WAS WIPED WITH GAUZE. NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568243 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA K4C35H

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR