BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20263670 · Received September 19, 2024

    Report

    Report Number
    2955842-2024-19431
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 26, 2024
    Report Date
    August 26, 2024
    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
    AK, 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 REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE IESU ASSOCIATED WITH THE CUSTOMER-REPORTED COMPLAINT. THE UNIT WAS ANALYZED AND WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE UNIT HAS NO SIGNIFICANT SCRATCHES OR DENTS. THE FRONT BEZEL IS IN DECENT CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VISION SYSTEM (VS) MONOPOLAR WAS NOT WORKING ON ERBE DUE TO THE RECURRING C-34 FAULT. TECHNICAL SUPPORT ENGINEER (TSE) VALIDATED BYPASS ELECTROSURGICAL UNIT (ESU) WAS A FORCE TRIAD AND SITE VERIFIED THE ERBE WAS PLUGGED INTO ITS OWN OUTLET, BUT THE ISSUE REMAINED, AND THE POWER CORD WAS NOT THE ORIGINAL ONE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335967 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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