BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14641042 · Received June 9, 2022

    Report

    Report Number
    2955842-2022-12077
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    May 9, 2022
    Report Date
    May 9, 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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 CUSTOMER STATED THAT THE ISSUE DISAPPEARED WHEN THE SYSTEM WAS RESTARTED AFTER THE PROCEDURE WAS COMPLETED. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1 AS A PREVENTIVE ACTION. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM INVOLVED WITH THIS COMPLAINT, BUT THE DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED FOLLOWING THE COMPLETION OF THE EVALUATION. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY THE ISI TECHNICAL SUPPORT WHEN THE CUSTOMER CALLED FOR TROUBLESHOOTING. INVESTIGATION REVEALED MULTIPLE ERRORS THAT MAY HAVE BEEN RELATED TO THE REPORTED COMPLAINT. ADDITIONAL LOG REVIEWS CONFIRMED THAT SYSTEM (B)(4) WAS USED ON (B)(6) 2022 FOR A RADICAL CYSTECTOMY WITH OTHER URINARY DIVERSION PROCEDURE. THIS COMPLAINT IS CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: A USM WAS DISABLED 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

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, AND H3 ANALYSIS INFORMATION CAN BE FOUND IN FIELDS H6 AND H10 INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED BUT DID NOT REPLICATE THE REPORTED COMPLAINT. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND PASSED NORMAL MODE. THE SYSTEM LOGS SHOWED ERRORS 1123,1174, AND 23068. DURING THE INSPECTION OF THE CARRIAGE ASSEMBLY, NO DEBRIS OR PARTICULATE WAS FOUND ON THE INSTRUMENT STERILE ADAPTER (ISA) WINDOW OR ROTOR MIRRORS. THE FLEX CABLE WAS CHECKED AND FOUND TO BE FULLY CONNECTED. THE UNIT WENT THROUGH MORE TESTING ON THE PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) AND PASSED ALL REQUIRED TESTS. THE ISA PRINTED CIRCUIT ASSEMBLY (PCA) WILL BE REPLACED AS A PRECAUTION. NO PROBLEM WAS DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY W/ OTHER URINARY DIVERSION SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT REPEATED ERRORS OCCURRED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1. THE CUSTOMER REBOOTED AND PERFORMED EMERGENCY POWER OFF (EPO) OF THE SYSTEM, BUT THE ISSUE PERSISTED. THE CUSTOMER WOULD DISABLE THE USM 1 TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS CONTINUING AS PLANNED WITH NO REPORTED INJURY. A FIELD SERVICE ENGINEER (FSE) WOULD BE SENT TO FURTHER TROUBLESHOOT THE ISSUE. FOLLOW-UP WAS PERFORMED AND THE FOLLOWING INFORMATION WAS OBTAINED. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM, AND THERE WERE NO ERRORS. IT WAS CONFIRMED THAT THE CUSTOMER DISABLED USM 1 AND CONTINUE WITH THE PROCEDURE WITH THE OTHER 3 USM ARMS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH 3 USM ARMS.

    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
    2055785 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-37 N/A 00886874110720

    Patients

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