BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18545571 · Received January 19, 2024

    Report

    Report Number
    2955842-2024-10393
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Date of Event
    December 27, 2023
    Report Date
    December 27, 2023
    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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED AND FOUND TO HAVE ENERGY ACTIVATION ISSUE. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION/FAILURE ANALYSIS.

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. FSE REPLACED THE ERBE GENERATOR TO RESOLVE THE ISSUE. ISI RECEIVED THE ERBE GENERATOR INVOLVED WITH THE COMPLAINT; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION.

    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 A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE ERBE GENERATOR WAS NOT ACTIVATING INTERMITTENTLY. THE CUSTOMER STATED THAT THE SURGEON PRESSED THE PEDAL AND THERE WAS NO ENERGY ACTIVATION. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO ENSURE THAT THE 3 CONNECTORS ON THE BACK OF THE ERBE WERE TIGHT. THE CUSTOMER CALLED BACK THE FOLLOWING DAY AND STATED THE ISSUE CONTINUED. WHEN STARTING THE SYSTEM, THE ERBE CONTINUED TO ERROR. THE CUSTOMER WAS NOT SURE IF A FORCE TRIAD GENERATOR WAS AVAILABLE AND DECIDED TO SWITCH OUT THE VISION SIDE CART (VSC) FOR THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS A LOW ANTERIOR RESECTION. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT SWITCHING THE VSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123173 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES