BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE

    MDR report key: 2841249 · Received October 2, 2012

    Report

    Report Number
    2841249
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 2, 2012
    Manufacturer
    INTUITIVE SURGICAL INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR WOULD ONLY GET A PARTIAL CUT, THE MANUFACTURER REP SUGGESTED IT WAS THE DEVICE AND A NEW DEVICE WAS GIVEN AND IT PERFORMED ACCURATELY. THE NEW DEVICE WAS FROM THE SAME LOT NUMBER.UNFORTUNATELY THE DOCTOR HAD LIMITED RECOLLECTION OF THE EVENT WITH THE TIME THAT HAS PASSED SINCE THE INCIDENT. THE DAVINCI REPRESENTATIVE WAS PRESENT AND REPLACED THE DEVICE WITH THE NEW VESSEL SEALER WHICH PERFORMED WITHOUT DIFFICULTY. IT IS DIFFICULT TO DETERMINE FROM THE MD NOTES EXACTLY WHEN THE DEVICE FAILED DURING THE PROCEDURE. THERE WAS NO PATIENT HARM.THERE WERE 3 VESSEL SEALER RELATED ISSUES AT OUR FACILITY. THE DAVINCI DEVICE IS NEW TO OUR FACILITY AND PHYSICIAN USE WOULD HAVE BEEN LOW AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTUITIVE SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL INC. REF:410322 VER-04 S10120813

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR