BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20539381 · Received October 25, 2024

    Report

    Report Number
    2955842-2024-21020
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    October 3, 2024
    Report Date
    October 3, 2024
    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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A QUALITY ENGINEER REVIEW WAS COMPLETED, AND ADDITIONAL INFORMATION WAS OBTAINED: AS A PRECAUTION, THE YAW MM WAS REPLACED. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY THE INTUITIVE SURGICAL, INC. (ISI) QUALITY ENGINEER. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: 23062 - FAULTY MOTOR, ENCODER, AMPLIFIER, OR CONNECTOR. THE PROBABLE ROOT CAUSE WAS ATTRIBUTED TO A SENSOR ERROR ON THE UNIVERSAL SURGICAL MANIPULATOR (USM).

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE WAS ABLE TO REPRODUCE THE REPORTED PROBLEM. AN ERROR WOULD OCCUR WHEN THE FSE ATTACHED AN INSTRUMENT INTO THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND THE AXIS 5 DISK SPINED SLOWLY. THE FSE REPLACED THE USM TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. AT THE TIME OF THIS REPORT, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED AND THE REPORTED PROBLEM WAS CONFIRMED VIA THE ERROR LOGS BUT WAS NOT REPLICATED IN-HOUSE. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE ALL TESTS PASSED. THE UNIT WAS ALSO TESTED ON A TEST PLATFORM WHERE ALL REQUIRED TESTS PASSED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN ERROR 23062 OCCURRED ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THE CUSTOMER POWER CYCLED THE SYSTEM, BUT THE ISSUE PERSISTED. THE CUSTOMER HARD POWER CYCLED THE SYSTEM, AND THE ERROR WAS CLEARED. THE CUSTOMER WAS CONTINUING WITH THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER USED ANOTHER PATIENT SIDE CART (PSC) TO COMPLETE THE PROCEDURE. THE FIRST ERROR OCCURRED BEFORE ANESTHESIA. HOWEVER, WHEN THE SAME ERROR OCCURRED, THE PORTS WERE ALREADY PLACED. THERE WAS NO INJURY TO THE PATIENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093452 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES