BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 17981146 · Received October 20, 2023

    Report

    Report Number
    2955842-2023-19464
    Event Type
    Malfunction
    Date Received
    October 20, 2023
    Date of Event
    September 29, 2023
    Report Date
    September 29, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115343
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CORE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE REPORTED FAILURE. WHEN REVIEWING THE ERROR LOG, THERE ARE SEVERAL ERRORS 86 POINTING TO POWER DISTRIBUTION BOARD ADC FAULT- AND AN ANALOG TO DIGITAL CONVERTER VOLTAGE OUT OF RANGE. THE CORE WAS TESTED ON IN-HOUSE TEST SYSTEM. THE SYSTEM FAILED WITH ERROR 86. FA RAN A 30X POWER CYCLE WITH THIS PART, AND THE SYSTEM PASSED THE TEST. THE CORE REMAINED ON THE TEST SYSTEM FOR HOURS; IN NORMAL OPERATION, IT PERFORMED WITHOUT ANY ERROR. ALSO, THE POWER TRAY FAILED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INVESTIGATE THE REPORTED EVENT FURTHER. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE REPLACED THE CORE TO RESOLVE THE ISSUE. THE SYSTEM WAS READY TO USE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, A NON-RECOVERABLE FAULT OCCURRED. PRIOR TO CONTACTING INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT, THE CUSTOMER RESTARTED THE SYSTEM WITHOUT ANY SUCCESS. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) VIEWED THE SYSTEM EVENT LOGS AND COULD SEE ERROR CODE 86 POINTING TO THE IPD (INTUITIVE SURGICAL CORE POWER DISTRIBUTION). THE TSE ASKED THE CUSTOMER TO SHUT DOWN THE SYSTEM AND CYCLE THE VISION SIDE CART (VSC) BREAKER, BUT THE ERROR REMAINED. THE SURGEON DECIDED TO CONVERT TO LAPAROSCOPIC SURGERY. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT CONVERSION WAS DONE DUE TO SYSTEM FAILURE AND SAME TROCARS WERE USED. ALSO, THERE WAS NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078195 DA VINCI XI VISION SIDE SYSTEM, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380721-11 N/A 00886874115343

    Patients

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