BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23399887 · Received October 28, 2025

    Report

    Report Number
    2955842-2025-43176
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 14, 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
    OH, US
    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 EVENT. THE FSE WENT ON-SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER-REPORTED COMPLAINT BUT COULD NOT REPLICATE IT. THE REPORTED ISSUE WAS CONFIRMED THROUGH SYSTEM LOGS, WHICH RECORDED ERROR M-35 ON (B)(6) 2025. VISUAL INSPECTION SHOWED LIGHT SCRATCHES WITH PAINT TOUCH-UP ON THE COVER/HOUSING AND A DENT ON THE TOP RIGHT CORNER. DURING SYSTEM TESTING, THE ERBE DISPLAYED ERRORS M-B0-41 AND M-B0-60, WHILE THE ERBE ERROR LOG RECORDED ERRORS M-0B AND M-31. THE ERBE UNIT WILL BE SENT TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ERBE ENERGY DECREASING OVER THE LAST WEEK. THERE WAS NO OTHER INFORMATION AVAILABLE. TSE ATTEMPTED TO REVIEW THE SYSTEM LOGS, BUT ONSITE WAS NOT AVAILABLE. THERE WAS NO TROUBLESHOOTING PERFORMED AS THE BIOMEDICAL ENGINEER WAS NOT ONSITE. THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2799328 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-21 N/A 00886874110898

    Patients

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