BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SURGICAL SYSTEM - INTUITIVE

    MDR report key: 1172823 · Received August 7, 2008

    Report

    Report Number
    1172823
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 9, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGICAL PROCEDURE: TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND WASHINGS VIA ROBOTIC ASSISTANCE. BILATERAL PELVIC LYMPHADENECTOMY AND AORTIC LYMPH NODE SAMPLING VIA ROBOTIC ASSISTANCE. REDUCTION AND REPAIR OF UMBILICAL HERNIA. APPROXIMATELY ALMOST 2 HOURS INTO CASE, SURGEON NOTED HOLE IN TIP COVER AND IMMEDIATELY REMOVED TIP AND REPLACED WITH NEW TIP COVER. NO SPARK OR INJURY TO PT OCCURRED. TIP COVER PRESERVED FOR LATER INSPECTION. PHOTOS TAKEN OF TIP COVER AND SENT TO INTUITIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1