BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17761292 · Received September 15, 2023

    Report

    Report Number
    2955842-2023-18494
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 25, 2023
    Report Date
    August 25, 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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REVIEWED THE SYSTEM LOGS AND VERIFIED THE ERROR AS WELL AS REPRODUCED THE REPORTED PROBLEM. THE IESU AND THE ELECTRIC SCALPEL WERE REPLACED AND INSPECTED TO CONFIRM NORMAL OPERATION. THE IESU WAS FOUND FAULTY. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE IESU INVOLVED WITH THIS COMPLAINT; HOWEVER, THE FAILURE IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WAS ANALYZED AND THE REPORTED COMPLAINT COULD NOT BE REPRODUCED. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. M-02 ERROR IS IN ERROR LOG. IT WAS NOTED THAT TWO ERRORS OCCURRED ON ERBE AFTER 10 MINUTES OF POWER ON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HEMICOLECTOMY SURGICAL PROCEDURE, INTEGRATED ELECTRO SURGICAL UNIT (IESU) VIODV GENERATOR DISPLAYED PERSISTENT ERROR CODE M-02 AND THE BIPOLAR ENERGY COULD NOT BE FIRED OR ACTIVATED. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). TSE ADVISED THE USER TO TROUBLESHOOT BY PERFORMING A POWER CYCLE ON THE IESU AND CONNECTING TO ANOTHER POWER OUTLET, BUT THE PROBLEM PERSISTED. THE ISSUE DID NOT RESOLVE. THE USE OF THE IESU WAS DISCONTINUED AND AN EXTERNAL GENERATOR (FT10) WAS USED TO CONTINUE THE SURGICAL TASK. THE USER CONTINUED WITH THE PROCEDURE USING THE SAME SYSTEM. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE MEDICAL ENGINEER (ME) AND OBTAINED ADDITIONAL INFORMATION. THE ME STATED THAT THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE WAS NO INJURY TO THE PATIENT AND CONFIRMED THAT A THIRD-PARTY GENERATOR WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299807 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-43 N/A 00886874110898

    Patients

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