BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 3121838 · Received May 15, 2013

    Report

    Report Number
    MW5030212
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 15, 2013
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ROBOT ARM ALARMED AND DISARMED DURING CASE. ERROR WAS NOT ABLE TO BE CLEARED WHEN THEY TRIED TO RESOLVE FAULT THE ARM WAS DISABLED. SURGERY COMPLETED WITH 3 ARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214334 DA VINCI ROBOT NAY INTUITIVE SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR