BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 23230841 · Received October 7, 2025

    Report

    Report Number
    2955842-2025-40799
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 12, 2025
    Report Date
    November 16, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE E-200 GENERATOR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE E-200 GENERATOR INVOLVED WITH THIS EVENT HAS BEEN RECEIVED, BUT THE FAILURE ANALYSIS TESTING HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE E-200 GENERATOR TO PERFORM FAILURE ANALYSIS (FA). THE E-200 WAS ANALYZED, AND FA INVESTIGATIONS COULD NOT REPLICATE OR CONFIRM THE CUSTOMER-REPORTED COMPLAINT. THE E-200 UNIT WAS VISUALLY INSPECTED, AND NO ISSUES WERE OBSERVED. IT WAS THEN INSTALLED ONTO A WELL-KNOWN SYSTEM AND POWERED ON SUCCESSFULLY. THE UNIT SUBSEQUENTLY PASSED THE SYSTEM DRIVE TEST. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS RESULTS. THE REPORTED EVENT WAS NOT CONFIRMED AS FAILURE ANALYSIS FOUND NO FUNCTIONAL ISSUES WITH THE E-200.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE USER INFORMED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT THE MONOPOLAR FUNCTION WAS NOT FIRING WITH THE ERBE GENERATOR. THE USER REPLACED THE MONOPOLAR ENERGY CABLE, BUT THE ISSUE PERSISTED. THE USER STATED THAT THEY COULD HEAR THE FIRING SOUND FROM THE ERBE, BUT NO ENERGY WAS COMING OUT. THE ISSUE WAS RESOLVED BY USING AN EXTERNAL ELECTROSURGICAL UNIT (ESU), WHICH ALLOWED THE COMBINATION OF CABLE AND INSTRUMENT TO WORK PROPERLY. THE USER CONTINUED WITH THE PROCEDURE AS PLANNED WITHOUT FURTHER ISSUES. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. A PROCEDURE DELAY OF 15 MINUTES WAS REPORTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2746214 DA VINCI ENERGY E-200 GENERATOR NAY INTUITIVE SURGICAL, INC 374897-33 N/A

    Patients

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