BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST ONE VESSELSEALER

    MDR report key: 2993192 · Received February 27, 2013

    Report

    Report Number
    MW5029210
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 21, 2013
    Manufacturer
    INTUITIVES SURGICAL INC
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE VESSEL SEALER WAS NOTED DURING THE CASE TO HAVE WIRES UNRAVELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84082 ENDOWRIST ONE VESSELSEALER VESSEL SEALER NAY INTUITIVES SURGICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention