BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16497580 · Received March 7, 2023

    Report

    Report Number
    2955842-2023-11133
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 9, 2023
    Report Date
    February 9, 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
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERBE ERRORS, 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 REPLACED THE ERBE DUE TO CONSTANT U-02 AND C-01 ERRORS. 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 ERBE WAS ANALYZED AND FOUND TO HAVE U-02 AND C-00 ERRORS. THE ISSUE WAS REPLICATED AND THE ERBE DISPLAYED ERROR U-02 DURING BOOT UP. THIS COMPLAINT IS REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: THE ERBE WAS REPLACED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH A FORCE TRIAD GENERATOR. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLIDING HIATAL HERNIA SURGICAL PROCEDURE, THE SYSTEM HAD ERRORS C-01 OCCURRED EACH TIME THE SURGEON ACTIVATED CAUTERY. THE SYSTEM LOGS CONFIRMED THE ERRORS REPORTED BY THE GENERATOR. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND INTEGRATED ELECTROSURGICAL UNIT (ERBE) ERRORS U-02 AND C-01, INDICATING AN INTERNAL FAILURE OF THE ERBE. THE CUSTOMER HAD SWITCHED TO AN ALTERNATE GENERATOR, AFTER POWER CYCLING THE ERBE DID NOT RESOLVE THE ISSUE. THE CUSTOMER CALLED BACK IN ASKING IF THE VESSEL SEALER INSTRUMENT COULD BE USED ON THE FORCE TRIAD GENERATOR. THE TSE EXPLAINED IT COULD NOT BE USED WITH THE FORCE TRIAD GENERATOR. THE CUSTOMER CALLED DURING THE PROCEDURE FOR GUIDANCE AND SOME QUESTIONS ON CONNECTING AND HOOKING UP THE FORCE TRIAD GENERATOR TO THE DA VINCI. THE PROCEDURE WAS COMPLETED WITH NO REPORTED 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
    140699 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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