BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 1100443 · Received July 25, 2008

    Report

    Report Number
    1100443
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 3, 2008
    Report Date
    July 25, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE END OF TROCAR APPEARED TO BE SLIGHTLY BENT AT THE INSERTION SLEEVE, SCRAPING THE INSTRUMENT SLIDING THROUGH IT. THIS LEFT METAL SHAVINGS IN THE PATIENT'S ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI TROCAR GCJ INTUITIVE SURGICAL, INC 420002-02 SA073905

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR