BEUDAMED
    FDA Adverse Event Other Summary report: N

    MARYLAND DISSECTOR

    MDR report key: 1031621 · Received April 16, 2008

    Report

    Report Number
    MW5006309
    Event Type
    Other
    Date Received
    April 16, 2008
    Date of Event
    March 18, 2008
    Report Date
    April 9, 2008
    Manufacturer
    AESCULAP
    Product Code
    GDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FACILITY HAS A REASON TO BELIEVE THAT THE DESCRIBED EQUIPMENT MAY HAVE CAUSED INJURY TO THE PT. PT HAD SEVERAL SURGERIES WHERE THIS PRODUCT WAS USED. FACILITY HAS EQUIPMENT SEQUESTERED, BUT CAN NOT VALIDATE IF THIS PARTICULAR PRODUCT OR ONE LIKE THIS MALFUNCTIONED. THERE IS A 'DEFECT' IN THE SHAFT OF THE MARYLAND DISSECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND DISSECTOR LAPARSCOPIC GDI AESCULAP

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other