BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETRIO

    MDR report key: 2150704 · Received July 6, 2011

    Report

    Report Number
    3005075853-2011-02776
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. CUSTOMER WILL NOT RELEASE DEVICE. ADDITIONAL INFORMATION: THE INITIAL PROCEDURE WAS FOR A LAPAROSCOPIC OOPHORECTOMY PERFORMED ON (B)(5) 2011. WE BROUGHT HER BACK FOR EXPLORATORY LAPAROTOMY AND BOWEL REPAIR ON (B)(6) 2011. THE BLADE DEPLOYED OUTSIDE THE CURVED JAWS OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP OOPHORECTOMY PROCEDURE, THE DEVICE DEPLOYED AND CREATED HARM TO THE PATIENT BY DAMAGING THE BOWEL. THE DEVICE WILL NOT BE RELEASED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK G4TX4P

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR