BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 2792352 · Received October 16, 2012

    Report

    Report Number
    3005075853-2012-04720
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 3, 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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). ADDITIONAL INFORMATION: IS DEVICE SOFTWARE VERSION KNOWN? YES - SOFTWARE VERSION X. IS THE DEVICE STILL UNDER WARRANTY? NO. IS THE DEVICE SUBJECT TO REGULAR SAFETY INSPECTIONS, MAINTENANCE OR CALIBRATION? YES. THE DEVICE WAS RECEIVED WITH THE ELECTRODE DETACH FROM THE INSTRUMENT AND NOT RETURNED. THE CERAMIC IS FRACTURED AND PARTIALLY MISSING. THE CERAMIC WAS DAMAGED BY THE SEPARATION OF THE ELECTRODE FROM THE LOWER JAW. VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED AND EVIDENCE OF ACTIVE ROAD WAS NOTED. TESTING FOUND A SHORT ON THE DEVICE WHEN THE JAWS ARE FULLY OR PARTIALLY CLOSED, CAUSING A REPLACE LIGHT TO ILLUMINATE. THE ACTIVE ROAD TOUCHES THE JAWS WHEN THEY ARE CLOSED, THE ACTIVE ROAD TO JAW CONTACT CREATES AN ELECTRICAL SHORT PREVENTING RF POWER DELIVERY FROM THE GENERATOR RESULTING IN THE REPLACE LIGHT ILLUMINATING ON THE RF60. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE ELECTRODE SEPARATED FROM THE JAW. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE ACTION IS UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THE PROCEDURE WAS PROLONGED FIVE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK H44MTX

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE