BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 3213873 · Received July 9, 2013

    Report

    Report Number
    3005075853-2013-03456
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 19, 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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AND THE CABLE CUT OFF THE DEVICE. THE CERAMIC WAS CRACKED BUT IS STILL BONDED TO THE LOWER JAW. DUE TO THE RETURNED CONDITION, FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE INSTRUMENT WAS DISASSEMBLED AND NO EVIDENCE WAS FOUND AS TO WHAT COULD HAVE CONTRIBUTED TO THE ACTIVATION ISSUES. IT IS POSSIBLE THAT A REPLACE INSTRUMENT WAS NOTED DURING USAGE WITH THE ELECTRODE SEPARATED IN THIS MANNER. THIS WAS NOT CONFIRMED DURING COMPLAINT ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY, THE DEVICE MALFUNCTIONED; AN ERROR WAS GIVEN TO REPOSITION THE JAWS. THE HANDPIECE WAS CHECKED. THE END OF THE JAWS WAS PEELING AWAY. A SECOND DEVICE WAS OPENED AND THE CASE WAS COMPLETED WITH NO DELAY OR PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314273 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK K4CL5C

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR