BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18731316 · Received February 19, 2024

    Report

    Report Number
    2955842-2024-11462
    Event Type
    Injury
    Date Received
    February 19, 2024
    Date of Event
    January 25, 2024
    Report Date
    January 25, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    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. BASED ON THE FIELD EVALUATION, THE REPORTED EVENT REGARDING PATIENT SIDE CART (PSC) RUNNING ON BATTERY WAS CONFIRMED. UPON ARRIVAL, A NON-RECOVERABLE ERROR WAS NOTICED ON TOUCHSCREEN AND THERE WERE NO STATUS LIGHTS ON THE UNIVERSAL SURGICAL MANIPULATORS (USMS). THE PSC WAS MANUALLY POWERED OFF AND UNPLUGGED FROM POWER SOURCE. WHEN THE PSC WAS PLUGGED BACK IN, THE FSE ONLY HEARD ONE OF THE TWO POWER SUPPLIES TURNING BACK ON. UPON VISUAL INSPECTION, FSE CONFIRMED POWER SUPPLY ONE WAS ON BUT POWER SUPPLY TWO WAS OFF. THE FSE REPLACED BOTH POWER SUPPLIES. AFTER BOTH POWER SUPPLIES WERE REPLACED, SYSTEM VERIFICATION WAS COMPLETED, AND FURTHER INVESTIGATION WAS PERFORMED REGARDING REPORT THAT SURGEON COULD NOT CONTROL ANY OF THE INSTRUMENTS. THE FSE FOUND NO RELATED ERRORS AND WAS NOT ABLE TO REPLICATE REPORTED ISSUE OF INABILITY TO CONTROL INSTRUMENTATION. THE SYSTEM WAS TESTED AND CONFIRMED READY FOR USE. ISI RECEIVED BOTH POWER SUPPLY SWITCHERS FOR ANALYSIS. THE CURRENT OF ONE OF THE POWER SUPPLY SWITCHERS WAS BELOW THE AVERAGE MINIMUM. THE OTHER POWER SUPPLY SWITCHER WAS ALMOST COMPLETELY DEAD (CURRENT WAS ALMOST 0) AFTER THE SYSTEM RAN 10 POWER CYCLES AND IT WAS NOTICED THAT THE FANS ON THE UNIT HAD STOPPED RUNNING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, AN OR STAFF MEMBER CONTACTED INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT A MESSAGE OF "WARNING PATIENT CART RUNNING ON BATTERY PLEASE PLUG IN" FOR APPROXIMATELY 20 MINUTES AND THAT THE SURGEON COULD NOT CONTROL ANY INSTRUMENTS ON THE ROBOT. THE REPORTER MENTIONED THAT PRIOR TO CALLING THEY HAD REBOOTED THE SYSTEM DUE TO RECEIVING A NON-RECOVERABLE ERROR. THE TSE VIEWED PROCEDURE LOGS AND OBSERVED ERRORS RELATED TO POWER ISSUE. HOWEVER, NO RELATED ERRORS OBSERVED REGARDING CONTROL OF INSTRUMENTS. AT THE TIME OF CALL TO TECHNICAL SUPPORT, THE REPORTER STATED THAT THE PROCEDURE WAS BEING CONVERTED TO OPEN SURGERY. NO TROUBLESHOOTING WAS PERFORMED AT THE TIME OF THE CALL. THERE WAS NO REPORTED PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530362 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-44 N/A

    Patients

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