BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17587287 · Received August 21, 2023

    Report

    Report Number
    2955842-2023-17880
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    July 26, 2023
    Report Date
    July 26, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE CONFIRMED THE ISSUE AND RESOLVED THE ISSUE BY REPLACING THE VIDEO PROCESSOR (VP). ISI RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE VP WAS INSTALLED INTO TEST EQUIPMENT. DURING THE BOOTING PROCESS, THE SYSTEM HAD ERRORS 48259 AND 833. THESE ERRORS ARE RELATED TO ERROR 252. FURTHER INVESTIGATION SHOWS THE WARNING ERROR RELATED TO THE DUAL WINDOW APPLIANCE (DWA) BOARD. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, A NON-RECOVERABLE FAULT 252 OCCURRED WHEN THE CUSTOMER PLUGGED IN THE CAMERA. THE CUSTOMER HAD POWERED DOWN THE SYSTEM. THE INTUITIVE SURGICAL INC. (ISI) TECH SUPPORT ENGINEER (TSE) CHECKED THE SYSTEM LOGS AND NOTED FAULT POINTED TO A COMMUNICATION ISSUE FROM THE CORE TO THE VIDEO PROCESSOR (VP). THE TSE HAD THE CUSTOMER CHECK THE GREY FIBER CABLE CONNECTION. THE CUSTOMER REPLACED THE CABLE, CHECKED THE POWER CORD TO THE VP, AND PERFORMED A HARD RESTART OF THE VISION SIDE CART (VSC), BUT ISSUE PERSISTED. THE TSE ADVISED THE CUSTOMER TO SWAP OUT VSCS. THE CUSTOMER STATED THEY WOULD DO THAT. THERE WERE NO REPORTS OF PATIENT INJURY. ISI HAS MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090630 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-27 N/A 00886874110898

    Patients

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