BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 1233446 · Received November 11, 2008

    Report

    Report Number
    1233446
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 11, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ROBOTIC PROSTATECTOMY THE ROBOTIC NEEDLE HOLDER TIP BROKE AND THE TIP WAS NOT ABLE TO HOLD THE NEEDLE. SOME OF THE INTERNAL CABLES/WIRES WERE VISIBLE AND STILL ATTACHED TO THE NEEDLE HOLDER. THERE WERE 2 MORE USES LEFT ON THE NEEDLE HOLDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOWRIST NEEDLE HOLDER, LARGE, ROBOTIC NAY INTUITIVE SURGICAL, INC. * M10080617

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR