BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 20348019 · Received October 1, 2024

    Report

    Report Number
    2955842-2024-19965
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    September 2, 2024
    Report Date
    September 2, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 WENT ON SITE, WAS NOT ABLE TO CONFIRM OVERHEATING ISSUE BUT REPLACED THE AIR FILTER DUE TO WEAR AND TEAR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE AFFECTED PART AIR FILTER INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOWER ANTERIOR RESECTIONS SURGICAL PROCEDURE, A CUSTOMER CALLED IN TO REPORT THAT THE SYSTEM WAS INDICATING THAT THERE WAS ON OVERHEAT CONDITION AND THAT IT MIGHT POWER OFF FOR SAFETY. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE LOGS THAT ARE SHOWING ERRORS 92, POINTING TO A CORE OVER TEMPERATURE CONDITION, AND ERROR 833, POINTING TO A TEMPERATURE WARNING ON THE VIDEO PROCESSOR (VP). THE TSE GUIDED NURSE TO CHECK IF THERE WAS DUST ON THE VIDEO PROCESSOR (VP), ENDOSCOPIC CONTROLLER (EC) AND CORE AIR FILTERS WHICH WAS THE CASE. THE TSE GUIDED NURSE TO REMOVE THE SUB-COMPONENT BEZELS AND CLEAN THE AIR FILTERS OUTSIDE THE OPERATING ROOM (OR). AFTER RESEATING THE CLEANED AIR FILTERS AND REPOSITIONING THE BEZELS, ERROR AND WARNING CLEARED. NEVERTHELESS, SURGEON WAS NOT WILLING TO PROCEED WITH THE SYSTEM AND DECIDED TO CONVERT TO OPEN SURGERY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE CONVERSION WAS SOLELY DUE TO SURGEON¿S DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948349 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other DA VINCI INSTRUMENTS AND ACCESSORIES