BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 23698730 · Received December 2, 2025

    Report

    Report Number
    2955842-2025-47183
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    October 7, 2025
    Report Date
    December 2, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116562
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS COULD CONFIRM BUT NOT REPLICATE OR VERIFY THE CUSTOMER REPORTED COMPLAINT. A REVIEW OF THE INSTRUMENT LOGS FOUND ERROR 48402. ADDITIONAL OBSERVATION(S) NOT REPORTED BY SITE: THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH MECHANICAL DAMAGE TO THE SCOPES DISTAL TIP. THE ENDOSCOPE CABLE INTEGRATED CONNECTOR WAS VISUALLY INSPECTED AND FOUND WITH DAMAGE. THE CABLE INTEGRATED CONNECTOR EXHIBITED CORROSION ON THE ELECTRICAL CONTACTS AND/OR CIRCUIT BOARD. THE ENDOSCOPE WAS PLACED THROUGH FRICTION TEST USING A SCREENING AID TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. THE ENDOSCOPE WAS TESTED AND PLACED ON IN-HOUSE SYSTEM OR EQUIVALENT FOR FUNCTIONAL TESTING AND FAILED TO PROVIDE A VIDEO DUE TO AN ELECTRICAL OR COMMUNICATION FAILURE. THE ENDOSCOPE WAS PLUGGED ON IN-HOUSE SYSTEM OR EQUIVALENT AND PROVIDED COLOR BARS IN BOTH EYES. THE ENDOSCOPE WAS PLACED ON AN IN-HOUSE DIAGNOSTIC TESTER AND FOUND WITH LOCAL BUTTON CONTROLS NOT WORKING PROPERLY. THE ENDOSCOPE FAILED THE BUTTON FUNCTIONALITY TEST DUE TO ALL BUTTONS. THERE WAS NO LIGHT IN ONE OR BOTH HIROSE FIBER CABLES. COMPONENT HAD A BROKEN OR DETACHED PIECE IN A LOCATION THAT COULD POTENTIALLY FALL INTO THE PATIENT. THE CAMERA INSTRUMENT EXHIBITED FLUID WITHIN INTERNAL COMPONENTS. THE ENDOSCOPE WAS TESTED AND PLACE ON AN IN-HOUSE SYSTEM FOR CABLE TESTING AND FAILED DUE TO WPB DEFECT. THE PROBABLE ROOT CAUSE OF THE CUSTOMER REPORTED ISSUE CANNOT BE DETERMINED SINCE THE ISSUE COULD NOT BE REPLICATED. THE PROBABLE ROOT CAUSE OF THE POTENTIAL FRAGMENT IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM AN ACCIDENTAL DROP OF THE ENDOSCOPE OR INADVERTENT COLLISIONS WITH OTHER INSTRUMENTS OR HARD SURFACES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 8MM 0-DEGREE ENDOSCOPE PLUS WAS BLURRY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900881 NONE ENDOSCOPE GCJ INTUITIVE SURGICAL, INC 470056-11 N/A 00886874116562

    Patients

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