BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18696990 · Received February 13, 2024

    Report

    Report Number
    2955842-2024-11138
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    January 19, 2024
    Report Date
    January 19, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. THE FSE REPLACED THE CORE POWER TRAY PER PROCEDURE TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE POWER TRAY ASSEMBLY INSTRUMENT WAS ANALYZED. THE REPORTED ERROR 86 WAS REPLICATED AND CONFIRMED. THIS CORE POWER TRAY ASSEMBLY WAS TESTED ON THE FINAL TEST IS4000 SYSTEM 1, PROGRAMMED, AND THE SYSTEM STARTED AT NORMAL MODE WITH NO ERROR TRIGGERED AT START UP. FA RAN 10X POWER CYCLES AND IT PASSED. HOWEVER, DURING THE 1-HOUR IDLE TEST IT TRIGGERED ERROR 86 POINTING TO IPD (INTUITIVE SURGICAL CORE POWER DISTRIBUTION). THE COMPLAINT WAS CONFIRMED BY THE FIELD EVALUATION AND FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE SITE HAD AN ERROR 86 NON-RECOVERABLE FAULT. CUSTOMER CALLED IN DURING CASE START, AFTER PORT PLACEMENT, TO REPORT AN ERROR 86. CUSTOMER STATED THE ERROR OCCURRED WHEN HE FIRST STARTED THE SYSTEM AND ONCE THEY POWER CYCLED, THE SYSTEM WAS GOOD UNTIL IT RETURNED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VIEWED THE SYSTEM LOGS AND CONFIRMED THE 86 ERROR. THE TSE EXPLAINED THAT EVEN THOUGH THE SYSTEM RUNNING WITH NO ERRORS, THERE WAS A POSSIBILITY THAT THE ERROR COULD RETURN. THE TSE ALSO CONFIRMED THE VISION SIDE CART (VSC) WAS PLUGGED INTO A GOOD OUTLET. THE CUSTOMER STATED THAT HE WILL HAVE TO DISCUSS THIS WITH THE SURGEON TO SEE HOW THEY WOULD LIKE TO PROCEED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOTIC ERROR DID CAUSE THE CASE TO BE ABORTED. THE CASE WAS NOT ABLE TO BE COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2158739 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-29 N/A 00886874110898

    Patients

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