BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 22375960 · Received July 1, 2025

    Report

    Report Number
    2955842-2025-27465
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 5, 2025
    Report Date
    June 5, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) SPOKE WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND INSTRUCTED TO REMOVE THE FILTERS WHICH COULD BE THE CAUSE OF THIS OVERHEATING IF THEY ARE DIRTY. THE CSR STATED THE FILTERS WERE REMOVED BY THE CUSTOMER AND BASED ON CUSTOMER FEEDBACK, THE DAY¿S SURGERIES WENT WELL AND THERE WAS NO OVERHEATING OF THE SYSTEM. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. A LOG REVIEW REVEALED TEMPERATURE WARNINGS POINTING TO THE VIDEO PROCESSING (VP) UNIT, WITH SUGGESTIONS TO CHECK FILTERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN OR NURSE INDICATED THAT THE SYSTEM SHUT DOWN BY ITSELF 2 MINUTES AFTER AN OVERTEMPERATURE ALARM WAS GENERATED. PRIOR TO CONTACTING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER HAD ALREADY REBOOTED THE SYSTEM BUT THE ISSUE PERSISTED. THE NURSE ALSO STATED THAT THE VISION SIDE CART (VSC) WAS NOISY TODAY IN THE FRONT. THE TSE INFORMED THE NURSE THAT THERE ARE THE FILTERS THERE BUT AS THEY ARE IN THE MIDDLE OF SURGERY, THEY WON'T OPEN IT TO KEEP THE OR STERILE. THE CUSTOMER WAS GOING TO CONVERT THE CASE TO OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382193 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 00886874110898

    Patients

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