BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22857755 · Received August 21, 2025

    Report

    Report Number
    2955842-2025-34967
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 24, 2025
    Report Date
    July 24, 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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER NOTICED THAT BIPOLAR FOOT SWITCH IN THE VISION SIDE CART (VSC) DRAWER MAKES PRESS SIGNAL EVEN IF IT IS NOT PRESSED. HE REPORTED THAT ERROR M-12S OCCURRED ON VIODV. TECHNICAL SERVICE ENGINEER (TSE) ASKED TO CHECK FOOT SWITCHES IN THE SHELF, BUT THEY WERE NOT PRESSED. ADVISED TO RESEAT FOOT SWITCH CABLES BEHIND THE VIODV, HOWEVER, THE ISSUE WAS NOT RESOLVED AND HAND BIPOLAR WAS FIRED UNINTENTIONALLY. THE TSE RECOMMENDED STOPPING THE BIPOLAR ENERGY. NO SITE VISIT WAS CONDUCTED.

    Additional Manufacturer Narrative · 0

    CORRECTION- H8 HAS BEEN UPDATED TO INDICATE INITIAL USE OF DEVICE ANNEX C CODE UPDATED: C0201 ELECTRICAL/ELECTRONIC COMPONENT PROBLEM IDENTIFIED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER STATED THAT THERE WAS NO ARCING OBSERVED AND THAT THE INSTRUMENT INVOLVED WAS A FENESTRATED BIPOLAR FORCEPS. THERE WAS NO INJURY TO THE PATIENT AND THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, ERROR M-12S OCCURRED ON VIODV. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CALLER TO VERIFY THE FOOT SWITCHES IN THE SHELF, BUT THEY WERE NOT PRESSED. THE TSE ADVISED TO RESEAT THE FOOT SWITCHES, BUT IT DID NOT RESOLVE THE ISSUE, AND THE HAND BIPOLAR WAS FIRED UNINTENTIONALLY. THE TSE RECOMMENDED STOPPING THE BIPOLAR ENERGY. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443065 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-30 N/A 00886874110898

    Patients

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