BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 2822662 · Received November 7, 2012

    Report

    Report Number
    3005075853-2012-05051
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 16, 2012
    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). DATE SENT: (B)(4) 2012. INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. 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 LAP GASTRECTOMY, THE ELECTRODE PEELED AWAY, BUT IT DID NOT DETACHED FROM THE JAW. THE TARGET TISSUE WAS THICK. 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
    1 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR