BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST INSTRUMENT

    MDR report key: 1609392 · Received February 16, 2010

    Report

    Report Number
    MW5014762
    Event Type
    Injury
    Date Received
    February 16, 2010
    Date of Event
    January 18, 2010
    Report Date
    February 1, 2010
    Manufacturer
    INTUITIVE SURGICAL INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B) (6) MALE ABOUT TO UNDER GO ROBOTIC ASSISTED LAPAROSCOPIC PROSTATECTOMY, AS REPORTED BY SURGICAL NURSE ROBOTIC EQUIPMENT REVIEWED PRIOR TO START OF PROCEDURE. NOTED TWO ROBOTIC NEEDLE DRIVERS TO BE DEFECTIVE WITH BROKEN CABLES. ALSO DEFECTIVE A THIRD DRIVER, HOUSING CAME APART. A FORTH DRIVER WAS OPENED AND FOUND TO BE COMPLETE FOR USE. NO PATIENT INJURY REPORTED SINCE ABOVE WAS NOTED PRIOR TO START OF SURGICAL PROCEDURE. ADDENDUM: MFR CONTACTED, RESPONSE RECEIVED SAME DAY BY MS. (B) (6), ARRANGEMENTS MADE TO REPLACE DEFECTIVE ROBOTIC PARTS. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOWRIST INSTRUMENT LARGE NEEDLE DRIVER NAY INTUITIVE SURGICAL INC. 420006 M10090305 928
    2 ENDOWRIST INSTRUMENT LARGE NEEDLE DRIVER NAY INSUITIVE SURGICAL INC. M10090513 628
    3 ENDOWRIST INSTRUMENT LARGE NEEDLE DRIVER NAY INTUITIVE SURGICAL INC. M10090513 629

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention