BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 2133466 · Received June 14, 2011

    Report

    Report Number
    MW5021011
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 14, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING EXTENSIVE ESOPHAGEAL PROCEDURE: ROBOTIC ASSISTED IVOR LEWIS ESOPHAGOGASTRECTOMY, MEDIASTINAL, CELIAC AND PERIAORTIC LYMPHADENECTOMY WITH VATS, J-TUBE, GASTRIC MOBILIZATION AND OMENTAL PEDICAL FLAP. DURING THE PROCEDURE THERE WAS AN ISSUE WITH THE DST EEA ORVILE. THE SURGEON RELAYED THAT THE SUTURES DID NOT SEEM TIGHT AND THIS PRECIPITATED THE DISLODGE/DISCONNECT - X3 - OF THE DEVICE. THE THIRD TIME THERE WAS A CALL PLACED TO ENDOSCOPY REMOVE THE DEVICE DURING THE SURGERY. THERE WAS NO INJURY TO THE PT AS A RESULT OF THE EVENTS. THE MFR HAS BEEN NOTIFIED AND REMAINING LOTS WERE RETURNED AND REPLACEMENTS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DST SERIES EEA ORVIL 25MM DEVICE EEA ORVIL - 25MM GDW COVIDIEN DST SERIES EEA EEAORVIL25

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability