BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 3083140 · Received April 29, 2013

    Report

    Report Number
    3005075853-2013-02026
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 12, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED WITH THE ELECTRODE SEPARATED BUT IS STILL ATTACHED TO THE ACTIVE ROD AND THE CABLE CUT OFF. THE CERAMIC IS FRACTURED AND PARTIALLY MISSING. THE CERAMIC WAS DAMAGED BY THE SEPARATION OF THE ELECTRODE FROM THE LOWER JAW. FUNCTIONAL TESTING CANNOT BE PERFORMED DUE TO AN INSTRUMENT WITH CABLE CUT OFF WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, THE ELECTRODE PEELED AWAY. 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
    183282 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR