BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17102252 · Received June 10, 2023

    Report

    Report Number
    2955842-2023-16158
    Event Type
    Malfunction
    Date Received
    June 10, 2023
    Date of Event
    May 12, 2023
    Report Date
    May 12, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR, 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 CONDUCTED SANITY CHECK ON BOTH CART DRIVES WHICH CONTINUED TO REPRODUCE ERROR. THE FSE REPLACED THE UNIVERSAL POWER DISTRIBUTOR (UPD) AND THE ERROR CLEARED AND THE SYSTEM PINGED ITSELF AS READY. THE CART DRIVE OPERATED NORMALLY. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE FAILURE ANALYSIS (FA) INVESTIGATION REPLICATED/ CONFIRMED THE CUSTOMER REPORTED COMPLAINT. IN HOUSE FA FOUND THE SYSTEM STARTED UP FAILED WITH ERROR 31221 NODE AT PATIENT-SIDE POWER DISTRIBUTION BOARD (PPD) WHICH MEANS THE HARDWARE HIGH SIDE SWITCH FAULT FPGA LOGIC HAS DETECTED A FATAL LOSS OF POWER AND HIT THE FRL- THIS FAULT SHOWS THE FRL HAS BEEN HIT. THE SOFTWARE WILL LOG A FAULT BEFORE OR AFTER THIS THAT SHOWS WHICH HIGH SIDE SWITCH CAUSED THE FAULT. THE UPD FAILED AND ALL THE ARMS HAVE RED LED. THE COMPLAINT REGARDING SYSTEM FAULTED ERROR WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NISSEN FUNDOPLICATION ISOLATED SURGICAL PROCEDURE, THE CUSTOMER WAS PUTTING IN THE LAST STITCH WHEN THE SYSTEM FAULTED WITH AN ERROR AND WOULD NOT RECOVER. THE CUSTOMER POWER CYCLED THE SYSTEM AND THE SYSTEM FAULTED AT POWER UP. THE CUSTOMER USED A LAPAROSCOPY INSTRUMENT TO CUT THE LAST STITCH IN THE CASE AND THEN CLOSED UP TO FINISH THE CASE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING UP AND THE SYSTEM INITIALLY POWERED ON WITH NO ERRORS. THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL PORT INCISIONS THE PATIENT TOLERATED THE CHANGE WELL AND THERE WAS NO PATIENT INJURY. THERE WAS NO PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270951 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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