BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 3102884 · Received May 9, 2013

    Report

    Report Number
    3005075853-2013-02196
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    November 29, 2012
    Report Date
    April 23, 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
    MA, 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.

    Description of Event or Problem · 1

    RECEIVED A USER FACILITY MEDWATCH ADVISING THAT DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY, RIGHT SALPINGO-OOPHORECTOMY AND A LEFT OVARIAN CYSTECTOMY THE DEVICE WAS NOT WORKING. THE SCRUB TECH NOTICED THAT THE BLADE END WAS SEPARATED. (ELECTRODE LIFTED BUT NOT DETACHED) THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203857 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK J4AY2N

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR GENERATOR