BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 2961803 · Received February 14, 2013

    Report

    Report Number
    3005075853-2013-00624
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 30, 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
    UK
    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 AND THE ELECTRODE IS STILL ATTACHED TO THE ACTIVE ROD. THE CERAMIC IS FRACTURED BUT SECTIONS ARE STILL BONDED TO THE LOWER JAW. TESTING FOUND A SHORT ON THE DEVICE WHEN THE JAWS ARE FULLY OR PARTIALLY CLOSED, CAUSING A REPLACE LIGHT TO ILLUMINATE. THE SEPARATED ELECTRODE ALLOWS THE ELECTRODE TO BE TOUCHING THE JAWS WHEN THEY ARE CLOSED. THE ELECTRODE TO JAW CONTACT CREATES AN ELECTRICAL SHORT PREVENTING RF POWER DELIVERY FROM THE GENERATOR RESULTING IN THE REPLACE LIGHT ILLUMINATING ON THE RF60.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HYSTERECTOMY PROCEDURE THE SURGEON WAS USING THE DEVICE TO SEAL AND CUT OVARIAN VESSELS WHEN HE NOTICED THAT A FILAMENT WAS DISPLACED FROM THE JAW OF THE DEVICE. HE STOPPED USING THE DEVICE AND REMOVED IT FROM THE PATIENT. NO ADVERSE CONSEQUENCES REPORTED. PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65506 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK J4CJ7T

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR