BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 3061182 · Received April 16, 2013

    Report

    Report Number
    3005075853-2013-01828
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 28, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. 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. IT WAS ALSO NOTED THAT THE BATCH NUMBER WAS NOT PRESENT ON THE INSTRUMENT. THE CERAMIC IS FRACTURED BUT ATTACHED TO THE LOWER JAW. THE CERAMIC COULD HAVE BEEN 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, 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 THE ELECTRODE SEPARATED FROM THE JAWS BUT DID NOT DETACH DURING AN LSH PROCEDURE. CASE WAS COMPLETED WITH A SECOND DEVICE. NO PATIENT CONSEQUENCE. DEVICE WILL BE RETURNED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162609 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK K4C04G

    Patients

    Seq Age Sex Outcome Treatment
    1