BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19112942 · Received April 15, 2024

    Report

    Report Number
    2955842-2024-13452
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 15, 2024
    Report Date
    March 19, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. FSE SPOKE WITH THE STAFF WHO STATED THAT THE BIPOLAR WAS INTERMITTENTLY WORKING. FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ACCORDING TO ISI PROCEDURES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE IESU WAS FOUND TO CAUTERIZE, ENERGIZE AND RECOGNIZE INSTRUMENTS ON ALL PORTS. THE COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE BIPOLAR ENERGY WAS NOT WORKING. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE LOGS AND FOUND NO ERRORS. PRIOR TO CALLING IN, THE CUSTOMER SWAPPED THE ENERGY CORDS AND THERE WAS STILL NO BIPOLAR POWER. THE TSE COULD VERIFY THROUGH SYSTEM LOGS THAT THE BIPOLAR SETTINGS COULD BE SEEN. THE CUSTOMER WAS ABLE TO FIRE MONOPOLAR POWER. THE TSE HAD THE CUSTOMER CHANGE PORTS ON THE ERBE AND POWER CYCLE THE ERBE AND STILL NO BIPOLAR POWER. TSE ASKED THE CUSTOMER TO REPLACE THE INSTRUMENT, BUT THEY WERE UNWILLING TO DO SO. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407643 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-24 N/A 00886874110898

    Patients

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