BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14230982 · Received April 28, 2022

    Report

    Report Number
    2955842-2022-11275
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    March 28, 2022
    Report Date
    March 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
    IN, US
    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 FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) DUE TO HARD ERROR 23118. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED/REPLICATED THE REPORTED ERROR. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED NORMAL MODE AS IT TRIGGERED ERROR 23118. THE LOGS SHOWED SEVERAL ERRORS OF 23118 ON AXIS 3. INSERTION CHIPENCODER VIRTUAL ABSOLUTE (CVA) PRINTED CIRCUIT ASSEMBLY (PCA) WAS SWAPPED WITH A GOLD ONE AND RETESTED ON THE SYSTEM. ERROR 23118 WENT AWAY. THE ORIGINAL CVA PCA WAS RE-INSTALLED/RETESTED, AND ERROR 23118 CAME BACK. THE UNIT TESTED ON THE TEST PLATFORM USING GOLD INSERTION CVA PCA, AND IT PASSED ALL REQUIRED TESTS. INSERTION CVA PCA AND FLAT FLEX CABLE (FFC) WILL BE REPLACED AS A FIX TO THE REPORTED PROBLEM. THE ROOT CAUSE OF THE REPORTED ISSUE WAS ATTRIBUTED TO A COMPONENT FAILURE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY THE ISI TECHNICAL SUPPORT ENGINEER (TSE) DURING TROUBLESHOOTING. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: 23118 (ARM 2 USM AXIS 3: MOTOR ENCODER INCREMENTAL TRACK HAS SLIPPED, POSSIBLE DISCONNECTED ENCODER OR INTERMITTENT LOSS OF SIGNAL). NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS CONSIDERED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY-BENIGN SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED REPEATED ERRORS ON ARM #2. THE CUSTOMER DISABLED ARM #2 AND CONTINUED THE PROCEDURE WITH THREE REMAINING ARMS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED LIVE LOGS AND FOUND MULTIPLE ERRORS 23118 ON UNIVERSAL SURGICAL MANIPULATOR (USM) #2. THE TSE RECOMMENDED TO MAKE SURE THE ARM #2 REMAIN DISABLED UNTIL THE SYSTEM WAS POWER CYCLED. THE SITE CONTINUED THE PROCEDURE AS PLANNED WITH NO REPORTED PATIENT INJURY. FOLLOW UP WAS PERFORMED WITH THE ROBOTICS COORDINATOR AND ADDITIONAL INFORMATION WAS OBTAINED. THE REPORTED ERRORS WERE NOTED PRIOR TO STATING AND DURING THE PROCEDURE. THE OR STAFF DISABLED UNIVERSAL SURGICAL MANIPULATOR (USM) #2 AND COMPLETED THE PROCEDURE ROBOTICALLY WITH THREE REMAINING ARMS. THERE WAS NO PATIENT HARM/INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613594 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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