BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE SURGICAL INC.

    MDR report key: 6839240 · Received September 1, 2017

    Report

    Report Number
    MW5071925
    Event Type
    Malfunction
    Date Received
    September 1, 2017
    Report Date
    August 16, 2017
    Manufacturer
    INTUITIVE SURGICAL INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INTUITIVE SURGICAL TIP COVER ACCESSORY FOR USE WITH ENDO WRIST MONOPOLAR CURRENT SCISSORS CAN COME OFF DURING USE. THE TIP COVER SHOULD HAVE A MARKING TO ALLOW IT TO BE SEEN BY X-RAY IN THE EVENT THAT IT COMES OFF DURING THE CASE. (USED WITH THE DAVINCI ROBOT.) DIAGNOSIS OR REASON FOR USE: TIP COVER FOR MONOPOLAR SCISSORS FOR ROBOTIC CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618514 INTUITIVE SURGICAL INC. TIP COVER ACCESSORY NAY INTUITIVE SURGICAL INC. M10170505

    Patients

    Seq Age Sex Outcome Treatment
    1