BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18876992 · Received March 11, 2024

    Report

    Report Number
    2955842-2024-11959
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    February 14, 2024
    Report Date
    February 14, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS CHECKED FOR ANY ISSUES/MESSAGES PRIOR TO USE. THERE WERE NO INDICATIONS THAT THERE WERE ANY PROBLEMS BEFORE THE REPORTED ISSUE OCCURRED. THE SYSTEM WAS IN USE FOR 3 HOURS BEFORE THE ISSUE OCCURRED.

    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 INSPECTED ALL ELECTRONICS FOR SIGNS OF OVERHEATING REPLACED THE INTAKE FILTERS. ALTHOUGH THE FSE WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUE, THE FSE REPLACED THE AIR INTAKE FILTERS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE AFFECTED PART INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, A OVERHEATING MESSAGE WAS GENERATED ON ONE OF THE SURGEON SIDE CONSOLES (SSC). AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS, WHICH REFLECTED SSC #1 WAS REPORTING AN SSC OVERHEATING MESSAGE. THE ISI CLINICAL SALES REP (CSR) MOVED BOTH OF THE SSCS AWAY FROM THE WALL AND VERIFIED THERE WERE NO OBSTRUCTIONS ON THE SSCS. AN ERROR WAS THEN GENERATED, AND THE SYSTEM SHUT DOWN. THE SURGEON ELECTED TO CONVERT THE CASE TO OPEN SURGERY. THE TSE EXPLAINED THAT THE STAFF COULD DISCONNECT SSC #1 AND PROCEED WITH A SINGLE CONSOLE, BUT THE SURGEON HAD ALREADY ELECTED TO CONVERT TO OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2455480 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-14 N/A 00886874110744

    Patients

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