BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 21793661 · Received April 7, 2025

    Report

    Report Number
    2955842-2025-13712
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 26, 2025
    Report Date
    March 26, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE ENDOSCOPE; 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 THE30-DEGREE ENDOSCOPE PLUS FOR FAILURE ANALYSIS INVESTIGATION. THE ENDOSCOPE WAS ANALYZED AND 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. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH COSMETIC DAMAGE. DURING INSPECTION OF THE ENDOSCOPE CABLE INTEGRATED CONNECTOR, THE CABLE INTEGRATED CONNECTOR HOUSING EXHIBITED DISCOLORATION. VISUAL INSPECTION CONFIRMED. THE ENDOSCOPE WAS EVALUATED AND FOUND WITH A CAMERA INSTRUMENT ADAPTER DEFECT. THE ENDOSCOPE WAS PLACED THROUGH FRICTION TEST USING A SCREENING AIDE 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 CAMERA INSTRUMENT ADAPTER REMOVED FROM ENDOSCOPE HOUSING AND EVALUATED AND FOUND WITH AEA SHAFT BEARING CONTRIBUTING TO FRICTION. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH COSMETIC DAMAGE. DURING INSPECTION OF THE ENDOSCOPE HOUSING, THE HOUSING SHELL EXHIBITED LASER MARKING FADING AND/OR REMOVED. THE PROBABLE ROOT CAUSE OF THIS BINDING IS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY TO INCREASED FRICTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE PLUS WAS NOT ROTATING PROPERLY. THE PROCEDURE WAS COMPLETED WITH 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
    582656 NONE ENDOSCOPE PLUS NAY INTUITIVE SURGICAL, INC 470057-11 N/A

    Patients

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