BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14522957 · Received May 27, 2022

    Report

    Report Number
    2955842-2022-11830
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    April 27, 2022
    Report Date
    April 27, 2022
    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
    JA
    Reporter Occupation
    003

    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 ISSUE OF REPEATED RECOVERABLE ERROR 31243 WAS CONFIRMED UPON SYSTEM LOGS REVIEWED. THE VIDEO PROCESSOR (VP) SELF-TEST WAS NOT COMPLETED, AND THE SYSTEM DID NOT START. THE FSE REPLACED THE VP UNIT, WHICH RESOLVED THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE VP INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THAT THE VP WOULD NOT POWER UP ON THE TEST SYSTEM. THERE IS NO LED INDICATOR ON THE FRONT OR BACK OF THE VP. THE FANS WOULD NOT SPIN AND NO POWER WAS COMING FROM THE POWER DELIVERY (VPPD) ON THE VP. THE VPPD HAS FAILED. THE ISSUE IS INDICATIVE OF A COMPONENT FAILURE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TSE. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: ERROR 31243 - SUBSYSTEM STARTUP COMM FAILED. THE PSC OR SSC TIMED OUT AFTER 10 SECONDS AND FAILED TO COMMUNICATE WITH THE CORE. THE ERROR FAULT OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2022 USING SYSTEM SK2036 MATCHING THE DOCUMENTED EVENT DETAILS. NO FURTHER REVIEW IS REQUIRED AS THE LOGS WERE REVIEWED/ANALYZED AS PART OF THE ISI TSE 'S INVESTIGATION. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER ABORTED AFTER THE START OF THE PROCEDURE DUE TO REPEATED RECOVERABLE ERRORS. FSE PERFORMED FIELD EVALUATION AND REPLACED THE VP. FAILURE ANALYSIS CONFIRMED A COMPONENT FAILURE. 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 CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED UROLOGY SURGICAL PROCEDURE, AFTER SURGICAL PORT PLACEMENT, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT RECOVERABLE ERROR 31243 OCCURRED. THE ENDOSCOPE SELF-TEST COULD NOT BE FINISHED DUE TO THE ERROR. THE TSE REVIEWED THE ERROR LOGS AND CONFIRMED THAT REPEATED RECOVERABLE ERROR 31243, WHICH INDICATED COMMUNICATION ERROR BETWEEN CARTS, OCCURRED DURING THE SYSTEM BOOTING. THE TSE HAD THE CUSTOMER PERFORM HARD POWER CYCLE AND RESEAT THE SYSTEM CABLES, BUT THE ISSUE PERSISTED. AFTER THAT, THE TSE EXPLAINED TO THE CUSTOMER THAT THE SYSTEM COULD NOT BE USED. THE FIELD SERVICE ENGINEER (FSE) WOULD FOLLOW UP. THE PROCEDURE WAS ABORTED AND RESCHEDULED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE. THE CUSTOMER DID NOT KNOW IF THE SYSTEM WAS INITIALLY POWERED ON WITH ANY ERRORS. IT WAS UNKNOWN IF THERE WAS ANY HARM TO THE PATIENT. THE PROCEDURE WAS POSTPONED TO (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2768805 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-29 00886874110898

    Patients

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