BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18497814 · Received January 11, 2024

    Report

    Report Number
    2955842-2024-10220
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    December 21, 2023
    Report Date
    December 21, 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
    003

    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 REPLACED THE ERBE GENERATOR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION AND IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WAS ANALYZED, AND FAILURE ANALYSIS COULD NOT REPRODUCE NOR CONFIRM THE REPORTED FAILURE. THE UNIT ENERGIZED AND CAUTERIZED ALL PORTS AND RECOGNIZED INSTRUMENTS. REVIEW ERRORS LOG, THE UNIT SHOW ERRORS M-1C, M-32, M-11, C-00, M-1F, M-B0.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, THE BIPOLAR FIRE WAS WEAK. THE ISSUE WAS NOT RESOLVED BY REPLACING AN INSTRUMENT AND CABLE, ADJUSTING EFFECTS, REBOOTING THE VIO DV ERBE GENERATOR AND SWITCHING TO THE BOTTOM PORT. THE PROCEDURE WAS COMPLETED WITH THE THIRD-PARTY (FORCE TRIAD) GENERATOR. 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: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING UP AND IT INITIALLY DID POWER ON WITHOUT ERRORS. THE CUSTOMER CHANGED TO FORCE TRIAD GENERATOR AND CONTINUED THE PROCEDURE. THE PROCEDURE WAS ROBOTICALLY COMPLETED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692570 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-30 N/A 00886874110898

    Patients

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