BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21930667 · Received April 29, 2025

    Report

    Report Number
    2955842-2025-17447
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    April 2, 2025
    Report Date
    April 2, 2025
    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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED TO INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE. 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. THE ERBE WAS RETURNED FOR FAILURE ANALYSIS AND C-33 AND C-00 FAULTS, COULD NOT BE REPRODUCED. THE REPORTED PROBLEM WAS CONFIRMED USING SYSTEM LOGS FOR 25913 C-33 HIGH VOLTAGE FAULT. THE ERBE WAS TESTED USING THE SYSTEM AND THE UNIT ENERGIZED, CAUTERIZED, AND RECOGNIZED INSTRUMENTS AND NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE PROBABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME; HOWEVER, THE ISSUE COULD BE RELATED TO HIGH VOLTAGE, AN ELECTRICAL COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) THAT THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE GENERATOR WOULD NOT GROUND AND THREE GROUNDING PADS HAD BEEN USED TO NO AVAIL. THE CUSTOMER CONFIRMED THAT THEY WERE NOT USING AN APPROVED DA VINCI GROUNDING PAD. TSE PROVIDED ALL APPROVED GROUNDING PAD INFORMATION AND GROUNDING WOULD NOT BE ACHIEVED WITH THE CURRENT PAD AND AN APPROVED PAD WOULD BE NEEDED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: FIELD SERVICE ENGINEER (FSE) USED THE TEST GROUND COVIDIEN GENERATOR, AND THE ISSUE WAS PRESENT AND FSE WAS ABLE TO REPRODUCE THE ISSUE. THIS WAS A TRUE GENERATOR ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428267 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-43 N/A 00886874110898

    Patients

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