BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 21967219 · Received May 6, 2025

    Report

    Report Number
    21967219
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    April 17, 2025
    Report Date
    April 18, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    OUR ROBOT ARM DRAPE WAS MALFUNCTIONING AND NOT ALLOWING PROPER FUNCTIONING WITH THE DA VINCI INSTRUMENTS. WHEN REPLACING ONE INSTRUMENT FOR ANOTHER TOWARDS THE END OF THE CASE, THE ARM WAS CONNECTING WITH THE INSTRUMENT BUT THE DRAPE WAS MALFUNCTIONING AND NOT ALLOWING APPROPRIATE CONTROL OF THE ARM. THE DRAPE WAS DISCONNECTED AND RECONNECTED AND MULTIPLE INSTRUMENTS WERE USED TO TROUBLESHOOT AND VERIFY THAT IT WAS NOT AN INSTRUMENT PROBLEM, EACH INSTRUMENT STILL WORKED OK ON OTHER DRAPED ROBOT ARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1885499 NONE SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 470015 K13250228

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female