BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST DA VINCI

    MDR report key: 2852318 · Received November 19, 2012

    Report

    Report Number
    2852318
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 25, 2012
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DA VINCI THORACIC GRASPER BLACK PROTECTIVE COATING RIPPED BY METAL DA VINCI TROCAR. INSTRUMENT INSPECTED BY TWO DOCTORS AND STATED INSTRUMENT COATING APPEARED TO BE COMPLETE; WOUND INSPECTED NO COATING PIECES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOWRIST DA VINCI SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT,GRASPER NAY INTUITIVE SURGICAL, INC. 420343 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR