BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI 5

    MDR report key: 22060366 · Received May 21, 2025

    Report

    Report Number
    2955842-2025-21026
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    April 28, 2025
    Report Date
    April 28, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119747
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE FIELD SERVICE ENGINEER (FSE) FOLLOWED WITH THE CLINICAL SALES REPRESENTATIVE (CSR). THE CSR COMMUNICATED ONCE THE DIGITAL VIDEO INTERFACE (DVI) CABLE WAS REPLACED THE IMAGE WORKED. NO FURTHER TROUBLE SHOOTING NEEDED. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER BIOPSY SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE CUSTOMER REQUESTED ASSISTANCE GETTING A BK IMAGE TO POPULATE IN TILEPRO. THE CALLER HAS A HDMI/ VIDEO-IN, CONNECTION TO THE SURGEON SIDE CONSOLE 2 (SSC) TO VIEW THIRD-PARTY BK IMAGE. THE CUSTOMER WAS NOT ABLE TO GET THE BK TO RECOGNIZE. THE TSE CONFIRMED ALL TILEPRO SETTING AND CABLING WITH NO CHANGE TO THE TILEPRO VIEW. THE TSE THEN HAD THE CUSTOMER CONNECT THE BK DEVICE, POWER DOWN AND THEN BACK ON TO GET THE DA-VINCI TO RECOGNIZE TO NO AVAIL. THE TSE RECOMMENDED TRYING A NEW HDMI AND NEW BK DEVICE AS THE BK WAS NOT COMMUNICATING. THE OPERATING ROOM (OR) STAFF OPTED TO CONVERT TO OPEN WHILE THE ISSUES WAS BEING TROUBLESHOT. THE CSR REQUESTED A NEW HDMI AND POSSIBLE BK FROM THE CUSTOMER AND ENDED THE CALL. THE CUSTOMER MIGHT CALL BACK ONCE A REPLACEMENT BK AND HDMI CABLE WAS LOCATED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. THE CSR CALLED BACK TO SEE IF THE VIDEO CONVERSION BOX, SHE BOUGHT AT A BIG BOX STORE WOULD WORK. THE CSR STATED THEY WERE TRYING TO HOOK UP VIDEO FROM THE BK ACTIVE WERE GOING TO TRY HOOK UP A DVI CABLE GOING FROM THE BK VIDEO OUTPUT THEN INTO THE CONVERSION BOX, THEN OUT OF THE CONVERSION BOX WITH A HDMI CABLE AND INTO THE CONSOLE HDMI INPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886497 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-45 N/A 00886874119747

    Patients

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