BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20203237 · Received September 12, 2024

    Report

    Report Number
    2955842-2024-19296
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 21, 2024
    Report Date
    August 21, 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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE UNIT WAS TESTED ON AND IN-HOUSE SYSTEM AND TRIGGERED ERRORS. THE UNIT WAS ALSO TESTED ON THE PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) AND FAILED FIBER ON THE CLOCK SPRING AND ROLLING LOOP. A GOLD CLOCK SPRING & ROLLING LOOP WAS INSTALLED, AND THE UNIT PASSED.

    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 REPLACED USM TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI) HAS RECEIVED THE USM FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED YET.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER HAD TO DISABLE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 DUE TO FAULTS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND NOTED SEVERAL FAULTS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM INITIALLY POWERED ON WITHOUT ANY ERRORS. THE PROCEDURE WAS COMPLETED ROBOTICALLY BY DISABLING ARM 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505001 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-42 N/A 00886874110720

    Patients

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