BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 13859285 · Received March 23, 2022

    Report

    Report Number
    2955842-2022-10711
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 20, 2022
    Report Date
    February 20, 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
    NV, US
    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 FSE POWERED THE SYSTEM ON AND AN ERROR 319 PROMPTED A NON-RECOVERABLE ERROR UNTIL ARM 3 WAS DISABLED. THE ISI FSE REPLACED THE INNER SET UP JOINT (SUJ) DISTAL ON ARM 3 TO RESOLVE THE ERROR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM PART INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE CUSTOMER REPORTED FAILURE OF ¿ERROR 319¿. THIS ERROR WAS ALSO FOUND IN THE ERROR LOGS. DURING THE PHYSICAL INSPECTION, THE SETUP FRU LOWER (SFL) PINS WERE FOUND TO BE DAMAGED. A GOLDEN SFL BOARD WAS INSTALLED AND THE SUJ PASSED ALL TESTS OF THE PFTP. AS A FIX, THE DISTAL SFL PCA WILL BE REPLACED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. 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 SUPPORT. INVESTIGATION REVEALED MULTIPLE ERRORS OCCURRED DURING THE SURGICAL PROCEDURE THAT WERE RELATED TO THE REPORTED COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO LAPAROSCOPIC PROCEDURE AFTER THE START OF THE PROCEDURE DUE TO NON-RECOVERABLE ERRORS. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, AN ERROR 319 WAS DISPLAYED. PRIOR TO CALLING IN, THE CUSTOMER UNDOCKED AND POWER CYCLED THE SYSTEM, AND THE SYSTEM POWERED ON WITH ARM 3 NOT FUNCTIONAL. THE SURGEON OPTED TO PROCEED WITH THE CASE LAPAROSCOPICALLY. THE TECHNICAL SUPPORT ENGINEER (TSE) OBSERVED ERROR 319 ON NODES 189-192. THE TSE WALKED THE CALLER THROUGH THE EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC) WITH NO CHANGE. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY. 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
    550973 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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