BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18664687 · Received February 7, 2024

    Report

    Report Number
    2955842-2024-11070
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    January 9, 2024
    Report Date
    January 9, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE FOUND THE POWER CORD WAS WARPED WITH EXPOSED WIRES; THE CORD WAS REPLACED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOMEONE EXPERIENCED A SHOCK FROM A POWER CORD TO THE PATIENT SIDE CART THAT WAS DAMAGED WITH A HOLE AND EXPOSED METAL WIRES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGICAL SCRUB TECH WHO WAS INVOLVED IN THE EVENT. SHE REPORTED AT THE TIME OF THE EVENT THE PATIENT SIDE CART WAS POWERED ON AND SHE WAS CLEARING EQUIPMENT OUT OF THE ROOM. SHE BEGAN TO MOVE THE PATIENT SIDE CART; THE POWER CORD AND BLUE CABLE WERE WRAPPED TOGETHER ON THE HANDLE OF THE PATIENT SIDE CART. WHEN SHE GRABBED THE HANDLE AND POWER CORD, SHE SAW A SPARK AND FELT A SHOCK TO HER LEFT PALM, RIGHT BELOW HER THUMB IN THE MEAT AREA OF HER PALM. IMMEDIATELY SHE DROPPED THE POWER CORD. THE POWER CORD WAS INSPECTED, A HOLE WAS FOUND IN THE INSULATION AND BARE METAL WIRES COULD BE VISUALIZED. THE POWER WAS TURNED OFF TO THE SYSTEM AND UNPLUGGED. IT WAS CONFIRMED WHEN THE UNIT WAS PLUGGED IN IT WAS PLUGGED INTO A RED POWER OUTLET. THE SYSTEM WAS TAKEN OUT OF SERVICE AND BIOMED WAS CALLED. THE SURGICAL SCRUB TECH DESCRIBED THE SHOCK AS A VERY PAINFUL "ZAP" LASTING ABOUT A MINUTE AND THEN WENT AWAY. THERE WAS NOT A BURN, REDNESS OR A MARK LEFT ON THE SKIN. SHE STATED SHE DID NOT NEED TO SEE EMPLOYEE HEALTH, OR A PHYSICIAN OR SEEK ANY TYPE OF MEDICAL INTERVENTION DUE TO THIS EVENT. SHE DID NOT SHARE HER DEMOGRAPHICS BUT SAID SHE HAS NOT HAD ANY MEDICAL HEALTH ISSUES IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2158019 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-35 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DA VINCI INSTRUMENTS AND ACCESSORIES