BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 16491904 · Received March 6, 2023

    Report

    Report Number
    2955842-2023-11103
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    February 8, 2023
    Report Date
    February 8, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A NON-RECOVERABLE FAULT ON UNIVERSAL SURGICAL MANIPULATOR 1 (USM1) NEAR THE END OF THE SURGICAL PROCEDURE, 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 REPRODUCED THE REPORTED ISSUE AND REPLACED USM1 TO RESOLVE THE REPEATED ISSUE OF ERROR 319. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE USM UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED NORMAL MODE. THE UNIT ALSO FAILED ALL BOARD PRESENT TEST. ERROR LOG SHOWED THAT AXES CONTROLLER ARM (ACA) WAS NOT DETECTED. THE ACA WAS SWAPPED WITH NEW ONE. THE UNIT WAS THEN RETESTED, AND ALL BOARDS TEST PASSED. THE ORIGINAL ACA WAS REINSTALLED, AND THE ERROR RETURNED. THE COMPLAINT REGARDING THE NON-RECOVERABLE FAULT ON USM1 WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO COMPONENT FAILURE. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE CUSTOMER EXPERIENCED A NON-RECOVERABLE FAULT AFTER THE START OF THE PROCEDURE. ALTHOUGH THE CUSTOMER WAS ABLE TO COMPLETE THE PROCEDURE, THE REPORTED ISSUE WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT 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 NEAR THE END OF A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CLINICAL TERRITORY ASSOCIATE (CTA) REPORTED UNIVERSAL SURGICAL MANIPULATOR 1 (USM1) FAULTED. THE CTA STATED THE USM WORKED FINE THE WHOLE PROCEDURE THEN SUDDENLY FAULTED WITH A RECOVERABLE FAULT AND WHEN RECOVERED, TURNED INTO A NON-RECOVERABLE FAULT. THE CUSTOMER PERFORMED A SOFT REBOOT OF THE SYSTEM PRIOR TO CALLING IN; HOWEVER, THE ISSUE REMAINED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED SEVERAL ERRORS WITH USM1 RELATED TO COMMUNICATION. THE TSE ASKED IF ADDITIONAL TROUBLESHOOTING COULD BE PERFORMED; HOWEVER, THE TROUBLESHOOTING WAS DECLINED AT THE TIME DUE TO IT BEING NEAR THE END OF THE SURGICAL PROCEDURE. THE TSE ADVISED A HARD POWER CYCLE OF THE PATIENT SIDE CART (PSC) AFTER THE PROCEDURE TO TRY TO RESOLVE THE ISSUE. THE CTA STATED THAT WOULD BE PERFORMED AFTER THE PROCEDURE AND BEFORE THE NEXT ONE. THE TSE COLLECTED CASE INFORMATION AND CALL ENDED. THE CTA CALLED BACK AND NOTED THAT THEY HARD REBOOTED THE SYSTEM AND 319 ERROR CONTINUED TO COME BACK FOR UNIVERSAL SURGICAL MANIPULATOR 1 (USM1). THE PROCEDURE WAS COMPLETING AS PLANNED 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
    707091 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-35 N/A 00886874115404

    Patients

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