BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17074313 · Received June 6, 2023

    Report

    Report Number
    2955842-2023-15986
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    August 18, 2021
    Report Date
    August 18, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 WAS ABLE TO DUPLICATE THE FAULT AT SYSTEM START. FSE SWAPPED FIBERS ON CORE AND THE ISSUE WAS RESOLVED. ALL PORTS TESTED WITH NOTHING UNUSUAL FOUND. THE FSE WAS THEN PROACTIVELY REPLACED THE VIDEO PROCESSOR (VP) DUE TO FIBER FAULTS FROM THE VP. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE VP ASSEMBLY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION COULD NOT REPRODUCE THE CUSTOMER REPORTED COMPLAINT. HOWEVER, THE ERROR/FAULT WAS CONFIRMED VIA ERROR LOGS/SYSTEM LOGS. THIS CASE WAS OPENED TO ADDRESS CUSTOMER CONCERN WITH INTERMITTENT FIBER ERRORS AT THE VIDEO PROCESSOR (VP). CUSTOMER ALSO REPORTS LOSS OF CONTROL OF ARMS. ERROR LOGS SHOWED 2 OCCURRENCES OF ERROR 41, 3 OCCURRENCES OF ERROR 40084 AT THE VIDEO CAMERA ALGORITHM PROCESSOR (VCA1) NODE, AND 1 OCCURRENCE OF ERROR 23 POINTING TO THE VPFI. THE VP WAS INSTALLED WITH A PCA TEST SYSTEM AND KNOWN-OPERATIONAL FIBER CABLES, THEN LAUNCHED IN MAINTENANCE MODE TO PROGRAM UNIT SOFTWARE. THE SYSTEM WAS POWER CYCLED 10X, THEN SAT IDLE IN NORMAL MODE FOR 15 MINUTES WITHOUT ERROR. THE POSITION OF THE ENDOSCOPE WAS MANIPULATED FROM THE SURGEON SIDE CONSOLE (SSC) WITHOUT ERROR, AND ALL ENDOSCOPE FUNCTIONALITIES WERE OPERATIONAL. IMAGE QUALITY WAS CLEAR AND CRISP, WITH NO NOISE OR DISCOLORATION ISSUES OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON WAS UNABLE TO TAKE CONTROL OF THE ARMS. THE CUSTOMER MENTIONED THAT THEY PERFORMED A SYSTEM POWER CYCLE WITH NO SUCCESS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VERIFIED NO ERRORS WERE FOUND IN THE LIVE LOGS. THE CUSTOMER ALREADY CONVERTED THE PROCEDURE TO A LAPAROSCOPIC SURGERY BEFORE CALLING TECHNICAL SUPPORT. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233929 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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