BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 25223997 · Received May 19, 2026

    Report

    Report Number
    2955842-2026-25723
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 19, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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. THE FSE REPLACED ENDOSCOPE SYSTEM CONTROLLER (ESC) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER OBSERVED A MESSAGE INDICATING POOR IMAGE QUALITY ON THE ENDOSCOPE AND AN INABILITY TO USE FIREFLY, EVEN AFTER THE ENDOSCOPE WAS REPLACED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FIRST GUIDED THE CUSTOMER THROUGH RESETTING THE IMAGE SETTINGS ON THE SYSTEM, BUT FIREFLY FUNCTIONALITY REMAINED UNAVAILABLE. THE TSE THEN ASKED THE CUSTOMER TO RESTART THE SYSTEM, AND AFTER THE RESTART THE SYSTEM INITIALLY APPEARED TO FUNCTION NORMALLY UNTIL ERROR 48392 OCCURRED. THE CUSTOMER ELECTED TO USE THE VISION SIDE CART (VSC) FROM ANOTHER DA VINCI SYSTEM TO CONTINUE THE CASE. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540684 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-50 N/A 00886874119662

    Patients

    Seq Age Sex Outcome Treatment
    1