BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 13862066 · Received March 23, 2022

    Report

    Report Number
    2955842-2022-10713
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 21, 2022
    Report Date
    February 21, 2022
    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
    GM
    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 CONFIRMED BASED ON THE FIELD EVALUATION. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE USM HAS BEEN RECEIVED, BUT ANALYSIS HAS NOT BEEN COMPLETED YET. A FOLLOW-UP MDR WILL BE SUBMITTED POST FAILURE ANALYSIS EVALUATION OR IF ADDITIONAL INFORMATION IS RECEIVED. ISI TECHNICAL SUPPORT ENGINEER (TSE) VIEWED ONSITE LOGS AND NOTED ERROR 23068 POINTING TO A LATENCY SENSOR ERROR ON UNIVERSAL SURGICAL MANIPULATOR (USM3). THERE WAS NO PHOTO OR VIDEO PROVIDED BY THE SITE FOR REVIEW. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AN 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 AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A CONVERSION.

    Additional Manufacturer Narrative · 0

    D02 - INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE REPORTED FAILURE (RECOVERABLE ERROR 23068) WAS CONFIRMED AND REPLICATED. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED NORMAL MODE AS IT TRIGGERED ERROR 23068. LOGS RECORDED ERRORS OF 23068 ON DOF 5. WHEN THE CARRIAGE ASSEMBLY WAS INSPECTED, IT FOUND NO HAZE/ DEBRIS ON ROTOR MIRRORS OR ON ISA WINDOWS, HALL SENSOR FFC WAS FULLY CONNECTED. THE ISA REPLACED WITH A GOLD ONE AND RETESTED ON A SYSTEM, ERROR WENT AWAY. WHEN THE ORIGINAL ISA REINSTALLED AND RETESTED, ERROR 23068 CAME BACK. THE UNIT WENT THROUGH MORE TESTING ON PFTP (USING GOLD ISA) AND IT PASSED ALL REQUIRED TESTS. ISA PCA WILL BE REPLACED AS A FIX TO THE REPORTED PROBLEM. UPDATED MDR FIELDS: ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, AND H3. FAILURE ANALYSIS INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: H6 AND H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD RECOVERABLE FAULT 23068. THE CUSTOMER RESTARTED THE SYSTEM BUT THE ISSUE REMAINS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND COULD CONFIRM ERROR 23068 POINTING TO A LATENCY SENSOR ERROR ON UNIVERSAL SURGICAL MANIPULATOR (USM3). THE TSE GUIDED THE CUSTOMER TO PERFORM ANOTHER RESTART WITH AN EMERGENCY POWER OFF (EPO), BUT ISSUE PERSISTED. THE TSE EXPLAINED THE CUSTOMER THAT THEY CAN DISABLED THE USM3 AND USE THE SYSTEM AS A 3 ARMS SYSTEM. NURSE WAS ABLE TO DISABLE ARM 3. THE SURGEON AGREED TO PROCEED WITH 3 ARMS. THE PROCEDURE CONTINUED AS PLANNED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE REPORTER ABOUT THE COMPLAINT: IT WAS CONFIRMED THAT THE ISSUE OCCURRED DURING A PROCEDURE. THE SYSTEM FUNCTIONALITY WAS CHECKED PRIOR TO STARTING THE PROCEDURE. THERE WAS NO EXTERNAL INTERFERENCE THAT CAUSED THE ISSUE.

    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
    715482 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-32 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES