BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17802296 · Received September 22, 2023

    Report

    Report Number
    2955842-2023-18672
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    August 30, 2023
    Report Date
    August 30, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A POWER PROBLEM, 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 INSPECTED SYSTEM FOR NO BATTERY BACKUP THE FSE NOTES THAT ON ARRIVAL WAS NOT ABLE TO POWER SYSTEM ON IN NORMAL MODE AS NO POWER WAS BEING DELIVERED TO SYSTEM. THE FSE CALLED TSE FOR FURTHER ADVICE REGARDING ISSUE. THE FSE WAS ADVISED TO REPLACE BOTH RMGPS INCLUDING LOAD SHARING CABLE TO SEE IF SYSTEM STARTS UP. THE FSE REPLACED THE POWER SUPPLY SWITCH RMGPS INCLUDING LOAD SHARING CABLE ACCORDING TO ISI PROCEDURES. FE WAS ABLE TO START SYSTEM ON AND NOTES THAT BATTERY CHARGING INDICATOR WAS DISPLAYING BATTERY IS CHARGING. FE PERFORMED SYSTEM VERIFICATION ACCORDING TO ISI PROCEDURES. THE FSE REVIEWED LOGS WITH TSE AND NOTES NO ERRORS TO BATTERY/POWER SUPPLY. THE FSE NOTES THAT BEFORE LEAVING SITE, VERIFIED THAT BATTERY CHARGED UP TO SECOND GREEN BAR OF THREE. SYSTEM IS VERIFIED READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE DA VINCI PRODUCTS TO PERFORM FAILURE ANALYSIS. THE POWER SUPPLY SWITCHERS WERE ANALYZED AND UNABLE TO REPLICATE THE REPORTED EVENT. LOGS SHOWED 90 OCCURRENCES OF ERROR 417, INDICATING THAT ONE OF THE POWER SUPPLIES IS NOT ACTIVE. THE CUSTOMER INSTALLED THE POWER SUPPLY UNIT ONTO THE TEST SYSTEM AND POWER CYCLED TEN TIMES WITHOUT ERROR. THE SYSTEM LAUNCHED IN NORMAL MODE. THE SYSTEM SAT IDLE IN NORMAL MODE FOR 30 MINUTES WITHOUT ERROR. THE SECOND POWER SUPPLY SWITCHER WAS TESTED AND ALSO HAD NO ERROR FOR 30 MINUTES OF TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THE PATIENT SIDE CART (PSC) TURNED OFF. CUSTOMER STATED THAT THEY WERE UNABLE TO RECOVER THE PSC AND BACKED IT UP AWAY MANUALLY. CUSTOMER BROUGHT IN ANOTHER PSC FOR THE PROCEDURE BUT HAVE NOT DOCKED IT YET. CUSTOMER STATED THAT ISSUE HAS BEEN ONGOING, AND THIS IS THE THIRD TIME THAT SHE'S CALLING ABOUT THIS. TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED THAT CUSTOMER CALL IN IF ADDITIONAL ASSISTANCE IS REQUIRED. CUSTOMER WAS REQUESTING FIELD SERVICE ENGINEER (FSE) TO FOLLOW UP AND SERVICE THE SYSTEM. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED AND NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) 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
    1241217 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-44 N/A

    Patients

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