BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI TIP COVER ACCESSORY

    MDR report key: 1971338 · Received January 10, 2011

    Report

    Report Number
    1971338
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 12, 2010
    Report Date
    January 10, 2011
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DAVINCI TIP COVER ACCESSORY DEVELOPED HOLES IN IT INTRA-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVINCI TIP COVER ACCESSORY DAVINCI TIP COVER ACCESSORY NAY INTUITIVE SURGICAL * C10229

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR