BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 22865229 · Received August 21, 2025

    Report

    Report Number
    2955842-2025-34915
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 28, 2025
    Report Date
    July 29, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    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 PROBABLE ROOT CAUSE OF THIS BINDING IS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY TO INCREASED FRICTION. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH COSMETIC DAMAGE. DURING INSPECTION OF THE ENDOSCOPE CABLE INTEGRATED CONNECTOR (IC), THE CABLE INTEGRATED CONNECTOR HOUSING EXHIBITED DISCOLORATION. THE ROOT CAUSE FOR CABLE CONNECTOR ¿ IC DISCOLORATION IS TYPICALLY ATTRIBUTED TO COMPONENT FAILURE. THE ENDOSCOPE WAS DETECTED WITH RATTLING OR NOISE FROM THE HOUSING AND DETECTED LOOSE BALLS FROM THE LED WINDOWS. THE ENDOSCOPE WAS DISASSEMBLED AND CONFIRMED WITH DISLODGED DESICCANT BALLS INSIDE BACKEND HOUSING. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY THROUGH EXTERNAL COLLISIONS, DURING USE, OR DURING REPROCESSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE PLUS FAILED CALIBRATION. IT WAS REVERSED/STANDS UPSIDE DOWN. 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
    2052376 NONE ENDOSCOPE PLUS NAY INTUITIVE SURGICAL, INC 470057-12 N/A 00886874116555

    Patients

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