BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 2223116 · Received August 25, 2011

    Report

    Report Number
    3005075853-2011-03516
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 25, 2011
    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). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. THE X-RAY SHOWS THE ELECTRODE IN THE PATIENT. THE DVDS SHOW: THE SECOND DEVICE WAS CLEARLY CERAMIC ELECTRODE SEPARATION, DVD NO.5 TIME 1:38:40 AND THE THIRD DEVICE - THIS IS THE DEVICE WHERE IT APPEARS THE ELECTRODE SEPARATED AND FELL OFF. DVD NO.7 TIME 01:30.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HEPATECTOMY PROCEDURE, 3 DEVICES WERE USED IN THIS OPERATION. WITH THE FIRST DEVICE, THE REPLACE LIGHT ILLUMINATED. WHEN THE 2ND AND 3RD DEVICES, THE ELECTRODE SEPARATED. WHEN THE PATIENT WAS X-RAYED AFTER THE OPERATION, A FRAGMENT OF SOMETHING WAS FOUND INSIDE THE PATIENT. THE SIZE WAS ALMOST SAME AS A CLIP. NO DEVICE WILL BE RETURNING. AT THIS TIME THE PIECE IS NOT BEING RETRIEVED. BIOCOMPATABILITY INFORMATION WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR GENERATOR