BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20697675 · Received November 15, 2024

    Report

    Report Number
    2955842-2024-21973
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 23, 2024
    Report Date
    October 23, 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
    TX, 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 EVENT. THE FSE FOUND THAT RECALIBRATED THE FLEX ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE SYSTEM WAS READY FOR USE. INTUITIVE SURGICAL INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT ASSOCIATED WITH THE CUSTOMER-REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED IN TO REPORT UNIVERSAL SURGICAL MANIPULATOR (USM) 4 WOULD NOT RECOVER A FAULT. THE CUSTOMER REPORTED ERROR AS A 23070 ERROR. PRIOR TO CALLING IN, CUSTOMER POWER CYCLED SYSTEM, BUT ERROR IMMEDIATELY CAME BACK. THE CUSTOMER AND STAFF OPTED TO BRING IN A SECOND PATIENT SIDE CART (PSC) TO CONTINUE WITH PROCEDURE BEFORE CALLING TECHNICAL SUPPORT. THE TECHNICAL SUPPORT ENGINEER (TSE) UNABLE TO TROUBLESHOOT FURTHER CUSTOMER IS CONTINUING PROCEDURE WITH SECOND PSC. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56562 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

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