BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15741609 · Received November 6, 2022

    Report

    Report Number
    2955842-2022-15130
    Event Type
    Malfunction
    Date Received
    November 6, 2022
    Date of Event
    October 10, 2022
    Report Date
    October 11, 2022
    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
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE NOTED THAT THE SYSTEM COULD NOT COMPLETE SELF-TESTS AND UNIVERSAL SURGICAL MANIPULATOR (USM) 1 WOULD FAULT. WHEN TRYING TO SYNC THERE WAS A MESSAGE THAT STATED MISSING NODES, AND THE FSE PROGRAMMED EVERYTHING ON THE NODE CONFIGURATION. THE FSE SHUT DOWN THE SYSTEM AND PERFORMED A HARD POWER CYCLE. THE SYSTEM RAN NORMAL AND WHEN SYNCING DID NOT SHOW THE PREVIOUS MESSAGE. THE FSE SHUT THE SYSTEM OFF A COUPLE MORE TIMES AND USM1 DID NOT FAULT. THE FSE PERFORMED A SYSTEM VERIFICATION AND THE SYSTEM WAS RUNNING NORMALLY. THE FSE COULD NOT REPLICATE ISSUE AFTER PROGRAMMING. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. NO IMAGE OR VIDEO WAS AVAILABLE FOR REVIEW. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TECHNICAL SUPPORT WHEN THE CUSTOMER CALLED FOR TROUBLESHOOTING ASSISTANCE AND FOUND NO RELATED ERROR RELATED TO THE REPORTED COMPLAINT. AN EVENT VERIFICATION CONFIRMED THE PROCEDURE WAS PERFORMED ON THE REPORTED EVENT DATE (B)(6) 2022 ON SYSTEM (B)(4). THIS COMPLAINT IS REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: AN USM WAS IN AN UNACCEPTABLE STATE AFTER THE START OF THE PROCEDURE. ALTHOUGH THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY, THE USM REQUIRED SERVICES TO CORRECT THE PROBLEM. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. 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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD INSERTION RESISTANCE ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1. PRIOR TO CALLING TO TECHNICAL SUPPORT, THE CUSTOMER RE-DRAPED USM1 BUT THE ISSUE PERSISTED. AN ISI TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED SYSTEM LOGS AND FOUND NO RELATED ERRORS. THE TSE ASKED THE CUSTOMER IF ANY DRAPE WAS BUNCHED UP UNDER THE CARRIAGE RESTRICTING THE INSERTION AXIS AND THE CUSTOMER DID NOT OBSERVE ANY ISSUE. THE TSE ASKED THE CUSTOMER TO POWER CYCLE THE SYSTEM. THE CUSTOMER OPTED TO PROCEED AND WOULD PERFORM A HARD POWER CYCLE ON THE PATIENT SIDE CART (PSC) AFTER THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. FOLLOW-UP ATTEMPTS HAVE BEEN PERFORMED TO REQUEST ADDITIONAL INFORMATION RELATED TO THE EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT NO FURTHER DETAILS HAVE BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2830201 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

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