BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17841131 · Received September 29, 2023

    Report

    Report Number
    2955842-2023-18839
    Event Type
    Malfunction
    Date Received
    September 29, 2023
    Date of Event
    September 6, 2023
    Report Date
    September 6, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND REPLICATED THE U-02 ACTIVATION ERROR. SYSTEM LOGS ALSO SHOWED THE U-02 ERROR OCCURRED IN THE PROCEDURE. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED BUT THE REPORTED U-02 ACTIVATION FAILURE COULD NOT BE REPRODUCED. THE IESU ENERGIZED, CAUTERIZED AND RECOGNIZED INSTRUMENTS ON ALL PORTS. A C-00 ERROR WAS IDENTIFIED IN THE SYSTEM LOG. THE IN-HOUSE TESTING OF THE RETURNED IESU REVEALED NO ISSUES RELATED TO THE CUSTOMER REPORTED EVENT. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, A U-02 ACTIVATION ERROR WAS TRIGGERED ON THE ERBE GENERATOR. THE CUSTOMER HAD ALREADY MOVED THE PROCEDURE TO ANOTHER DA VINCI SYSTEM BEFORE CONTACTING THE TECHNICAL SUPPORT ENGINEER (TSE). THE CUSTOMER STATED THAT THE ERROR OCCURRED PREVIOUSLY. THERE WAS NO REPORT OF PATIENT HARM. INTUITIVE SURGICAL INC. (ISI) MADE A FOLLOW-UP ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2272471 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES