BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20931699 · Received December 13, 2024

    Report

    Report Number
    2955842-2024-23204
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    November 19, 2024
    Report Date
    July 14, 2025
    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
    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). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT ISSUED THE RETURN OF THE IESU.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND UPON VISUAL INSPECTION THERE WERE NO ISSUES FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE ERBE WAS TESTED USING SYSTEM ON STARTUP UNIT DISPLAYED M-02-5, 4-88, WHEN TESTING INSTRUMENT DETECTION UNIT FAILED MONOPOLAR SLOT # 3 AND # 4 WHEN TESTING BIPOLAR SLOT 2 UNIT DISPLAYED ERROR 2-88.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED SITE WAS UNABLE TO USE THE MONOPOLAR CURVED SCISSORS (MCS) ON UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THEY ENCOUNTERED A QUESTION MARK AND MESSAGES TO CHECK THE INSTRUMENT CABLE. THEY HAD TRIED TWO DIFFERENT CABLES, AND THEY WERE STILL ENCOUNTERED A MESSAGE TO CHECK THE INSTRUMENT CABLE, AND THEY WERE GETTING A QUESTION MARK. TSE SUGGESTED THAT THEY TRY THE OTHER MONOPOLAR PORT BUT THERE WAS NO CHANGE. TSE SUGGESTED TO TRY POWER CYCLING THE EREBE GENERATOR, THEY DID NOT TRY POWER CYCLING THE GENERATOR. TSE SUGGESTED GETTING A THIRD INSTRUMENT CABLE, BUT THEY WERE CONTINUING TO HAVE SIMILAR ISSUES WHERE THE INSTRUMENT WAS NOT DETECTED END MESSAGES TO CHECK THE INSTRUMENT CABLE. WITHOUT MONOPOLAR ENERGY AND THEY WILL USE THE SYNCHROSEAL. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS A CHOLECYSTECTOMY. THE PROCEDURE WAS COMPLETED USING THE SYNCHROSEAL INSTRUMENT INSTEAD OF THE MONOPOLAR ENERGY. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE GENERATOR WAS NOT EXCHANGED DURING THE CASE. THE FIELD ENGINEER WAS CONTACTED, AND HE ARRIVED THE NEXT DAY TO TROUBLESHOOT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2418055 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-45 N/A 00886874110898

    Patients

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