BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19726203 · Received July 11, 2024

    Report

    Report Number
    2955842-2024-16472
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 13, 2024
    Report Date
    June 13, 2024
    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
    PA, US
    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. FSE REPLACED THE ERBE TO RESOLVE THE C CLASS ERRORS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA). THE ERBE WAS ANALYZED AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. ERRORS C-00 AND M-31 WERE PRESENT IN THE ERROR LOG. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. THE UNIT HAS NO SIGNIFICANT SCRATCHES OR DENTS. THE FRONT BEZEL IS NOT CRACKED. THE ERBE IS IN GOOD CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, THE CUSTOMER WAS GETTING ERRORS ON THE ERBE. BEFORE CALLING IN, THE CUSTOMER REBOOTED THE ERBE BUT THE ISSUE REMAINED. THE CUSTOMER WAS USING THE VESSEL SEALER EXTEND (VSE) WITH THE E-100, BUT THEY HOOKED UP THE VALLEY LAB FORCE TRIAD AND ARE GOING TO COMPLETE THE CASE WITH THAT. THE CUSTOMER STATED THEY WERE GETTING ERRORS M-31, C-00, AND C-30. THE TECHNICAL SERVICE ENGINEER (TSE) VIEWED SYSTEM LOGS AND CONFIRMED ERBE ERRORS. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346818 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-39 N/A 00886874110898

    Patients

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