BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14529072 · Received May 27, 2022

    Report

    Report Number
    2955842-2022-11843
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    April 28, 2022
    Report Date
    April 28, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. FSE REPLICATED THE ISSUE AND THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2 WAS REPLACED WITH NO FURTHER ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PART INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. DURING FAILURE ANALYSIS, THE USM ARM WAS TESTED AND FAILED IN NORMAL MODE RESULTING IN AN ERROR FAULT ON THE PITCH. FURTHER TESTING IDENTIFIED FAULTY COMPONENTS I.E. PITCH CHIPENCODER VIRTUAL ABSOLUTE (CVA) PCA, CVA2 FLAT FLEX CABLE (FFC) & CVA. THIS CONFIRMS THE REPORTED EVENT. THE PARTS WERE REPLACED TO RESOLVE THIS ISSUE. FOLLOWING THIS, THE USM ARM WAS TESTED, OPERATED WITH NO FURTHER ISSUE AND WAS RESTORED TO SPECIFICATION. A REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIED NO OTHER COMPLAINTS RELATED TO THE INSTRUMENT AND/OR THIS EVENT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. A LOG REVIEW CONFIRMED THE PROCEDURE DATE OF (B)(6) 2022 ON SYSTEM (B)(4)F. ADDITIONALLY, A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TECHNICAL SUPPORT ENGINEER (TSE). INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: ERROR 23118 ¿ ARM 2 USM AXIS 2: MOTOR ENCODER INCREMENTAL TRACK HAS SLIPPED, POSSIBLE DISCONNECTED ENCODER OR INTERMITTENT LOSS OF SIGNAL. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING 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 CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED A NON-RECOVERABLE FAULT ERROR: 23118 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AND IT KEPT COMING BACK EACH TIME THE ARM IS MOVED. SITE RESTARTED THE SYSTEM WITH NO CHANGE PRIOR TO CALLING TECHNICAL SUPPORT. SITE MOVED THE USM 2 OUT OF THE WAY (DISABLED IT) AND CONTINUED WITH THE REST OF THE USMS 1, 3 AND 4. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO PATIENT HARM. 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
    1877760 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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