BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21275388 · Received January 30, 2025

    Report

    Report Number
    2955842-2025-01022
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 6, 2025
    Report Date
    January 6, 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
    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 COMPLAINT. THE FSE REPRODUCE THE ISSUE AND REPLACED THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE IESU HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS ABLE TO CONFIRM ISSUE VIA SYSTEM LOGS AND REPRODUCE ISSUE DURING IN-HOUSE TESTING. THE UNIT WAS PLACED ON A SYSTEM AND WAS RUN IN NORMAL MODE. THE ROOT CAUSE WAS ATTRIBUTED TO A HIGH FREQUENCY VOLTAGE ISSUE.

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO COMPONENT FAILURE BASED ON ELECTRICAL AND FIBEROPTIC DEFECTS. MEASUREMENT VALUE FOR HF VOLTAGE TOO SMALL WITH ON FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) SALES ASSOCIATE CONTACTED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) REGARDING INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) ERRORS C-34 AND C-92. THE REPORTED COMPLAINT REMAINED AFTER THE CUSTOMER ATTEMPTED TO POWER CYCLE THE IESU MULTIPLE TIMES AND USE NEW INSTRUMENT ALONG WITH CABLES. ACCORDING TO THE SALES ASSOCIATE, A BACKUP GENERATOR WAS AVAILABLE, AND THEY WOULD BE SWITCHING TO THE BACKUP GENERATOR FOR THE SURGICAL PROCEDURE. A SECOND CALL WAS MADE TO TSE BY THE SALES ASSOCIATE REQUESTING ASSISTANCE WITH CONNECTING THE FORCE TRIAD GENERATOR. THE TSE ASSISTED THE SALES ASSOCIATE BUT WAS UNABLE TO GET THE MONOPOLAR ENERGY. THE SALES ASSOCIATE CONFIRMED THAT THE ENERGY CABLES AND GROUNDING PADS WERE CONNECTED TO THE FORCE TRIAD. TSE RECOMMENDED FOR THE CUSTOMER TO CHECK THEIR SETTINGS, AND THEY WERE CONFIRMED. THE SALES ASSOCIATE STATED THAT THE VISION SIDE TOWER WOULD BE SWAPPED. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORTED INJURY. ISI CONTACTED THE SALES ASSOCIATE AND THE SITE'S ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING INFORMATION: THE PROCEDURE WAS COMPLETED BY SWITCHING OUT THE VISION SIDE TOWER WITH ONE FROM ANOTHER ROOM.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758469 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-33 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES