BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SURGICAL SYSTEM - INTUITIVE

    MDR report key: 1172804 · Received August 7, 2008

    Report

    Report Number
    1172804
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 17, 2008
    Manufacturer
    INTUITIVE SURGICAL INC.
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGICAL PROCEDURE: ROBOT-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, REMOVAL OF 6X5 CM RIGHT OVARIAN MASS. DURING SURGICAL PROCEDURE, SPARK NOTED. TIP COVER CHANGED. NO INJURY TO PT OCCURRED. TIP COVER PRESERVED FOR LATER INSPECTION. PHOTOS TAKEN OF TIP COVER AND SENT TO INTUITIVE. TIP COVER INSPECTED FOR HOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVINCI SURGICAL SYSTEM - INTUITIVE MONOPOLARCURVED SCISSORS/TIP COVER NEY INTUITIVE SURGICAL INC. C8091

    Patients

    Seq Age Sex Outcome Treatment
    1