BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14740098 · Received June 19, 2022

    Report

    Report Number
    2955842-2022-12255
    Event Type
    Malfunction
    Date Received
    June 19, 2022
    Date of Event
    May 19, 2022
    Report Date
    May 19, 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
    PA, 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 REPORTED COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION. THE FSE COULD NOT RECREATE THE ISSUE ON SYSTEM START UP BUT SAW ERROR 26002 IN THE SYSTEM LOGS. THE FSE REPLACED PROXIMAL SET UP JOINT (SUJ)1 AND THE SYSTEM PASSED ALL DATA TERMINAL EQUIPMENT TESTING AFTER THE SUJ WAS REPLACED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION, BUT THE FAILURE ANALYSIS TESTING HAS NOT YET BEEN COMPLETED. THEREFORE, FAILURE ANALYSIS OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED. RFE REPORT REVIEW WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: THE CHOLECYSTECTOMY PROCEDURE TOOK PLACE ON (B)(6) 2022 VIA SYSTEM #SK4035. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TSE. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERROR(S): /26002/THE MIDDLEMAN ON THE PCTP IN THE PSC HAD A FAILURE IN BP EXECUTION FOR USM1 ¿ BPCODE: BP_AMP_SWITCH_MANIP (THIS CAN BE CAUSED BY ARM CHAIN COMM FAILURE), /307/NODE NOT PRESENT: ACS IN ARMNET1 USM ¿ A NODE CONFIGURED TO BE PRESENT HAS STOPPED RESPONDING. (THE NODE WAS PRESENT AT STARTUP), /31030/PSC SUBSYSTEM TIMED OUT ON STARTUP. WAITING FOR SUPERVISOR TO COMPLETE STARTUP ACTIONS. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: A USM WAS ABANDONED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY USING 3 ARMS. 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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PROXIMAL SET UP JOINT (SUJ) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION REPLICATED THE ERROR ON THE SYSTEM. THE SUJ UNIT WAS PUT ON THE TEST MACHINE WHERE IT FAILED FOR NODE CHECKS. LOG REVIEWS SHOWED ERRORS 26002. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE A COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED THE TECHNICAL SERVICE ENGINEER (TSE) AND STATED THAT THERE WAS A NON-RECOVERABLE 31030 ERROR. PRIOR TO THE CALL, THE CUSTOMER HAD POWER CYCLED THE SYSTEM BUT THE ERROR PERSISTED. THE TSE CONFIRMED MULTIPLE ARMNET 1 ERRORS IN THE LOGS. AFTER, THE TSE WALKED THE CUSTOMER THROUGH EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC) AND THE ERRORS RESOLVED. THE TSE STAYED WITH THE CUSTOMER ON THE PHONE AS THE SURGEON USED FOLLOW ON MATCHING GRIP AND ERROR 26002 PRESENTED. THE TSE WALKED THE CUSTOMER THROUGH EPO OF THE PSC AND THEN THE UNDOCKING OF UNIVERSAL SURGICAL MANIPULATOR (USM) 1 AND PROCEEDED USING USM2, USM3, USM4 (3 ARM CASE). THE PROCEDURE WAS CONTINUING AND THERE WAS NO REPORTED INJURY. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350584 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-49 N/A 00886874110720

    Patients

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