BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 10672903 · Received October 13, 2020

    Report

    Report Number
    2955842-2020-11078
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    September 18, 2020
    Report Date
    September 18, 2020
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    4307 - ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: D10, G4, G7, H2, H3, H6 AND H10. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SETUP STRUCTURE (SUS) MOTOR ASSEMBLY ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) CONFIRMED/REPRODUCED THE REPORTED ISSUE DURING SYSTEM START UP. FA CONCLUDED THAT THE CAUSE WAS DUE TO A FAULTY CHIPENCODER VIRTUAL ABSOLUTE PRINTED CIRCUIT ASSEMBLY (CVA PCA).

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGES OR VIDEOS WERE SHARED FOR THE EVENT. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED SYSTEM LOGS AND THE ERROR 23094 POINTED TO THE SETUP STRUCTURE ORIENTING PLATFORM (SUS OP) ROTATION. A SYSTEM LOG REVIEW WAS ALSO PERFORMED FOR THE SYSTEM SK2410 AND CONFIRMED ERRORS 23094 AND 23068 THAT THE CUSTOMER REPORTED. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS UNABLE TO REPRODUCE THE REPORTED ERROR 23094. AS A PRECAUTION, THE FSE REPLACED THE ORIENTING PLATFORM (OP) WRIST MOTOR. FOLLOWING SERVICE, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA HAS BEEN ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE ISI COMPONENT RETURNED; HOWEVER, ISI HAS NOT RECEIVED THE RMA TO CONFIRM/IDENTIFY ANY REPORTABLE FAILURE MODE(S). A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE (FIRST PORT INCISION) COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, THE SYSTEM ENCOUNTERED A RECOVERABLE FAULT WHEN THE SURGICAL STAFF WAS ABOUT TO DOCK THE SYSTEM TO THE PATIENT. THE SITE TRIED RECOVERING, BUT THE ERROR PERSISTED. TECHNICAL SUPPORT WAS CONTACTED AND THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED SYSTEM LOGS AND THE ERROR (23094) POINTED TO THE SETUP STRUCTURE ORIENTING PLATFORM (SUS OP) ROTATION. TSE HAD THE CUSTOMER HARD POWER CYCLE THE PATIENT SIDE CART (PSC), BUT THE ISSUE WAS NOT RESOLVED. THE SITE EXPLAINED THAT AN ERROR 23068 OCCURS FIRST AND WHEN THEY TRIED TO RECOVER AN ERROR 23094 OCCURS. THE TSE HAD THE SITE TRY ANOTHER PSC HARD POWER DOWN, BUT THE ERROR RETURNED. THE CUSTOMER THEN CONVERTED TO ANOTHER PSC (SK1272) AND PROCEEDED WITH THE CASE AS PLANNED. THERE WAS NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) COMPLETED FOLLOW-UP WITH THE CUSTOMER AND THE FOLLOWING INFORMATION WAS OBTAINED: THE ROBOTICS COORDINATOR CONFIRMED THAT SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM TURNED ON WITHOUT ISSUE. ALSO, THE SURGICAL STAFF COMPLETED THE PROCEDURE AFTER CONVERTING TO ANOTHER DA VINCI SYSTEM AND THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134562 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-43 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES