BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 22597419 · Received July 24, 2025

    Report

    Report Number
    2955842-2025-30835
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    July 7, 2025
    Report Date
    July 7, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THE 30-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(S) NOT REPORTED BY SITE: 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 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 VISUALLY INSPECTED AND FOUND WITH MINOR DEFORMATION TO THE CABLE INSULATION. THE DAMAGE WAS LOCATED THE ENDOSCOPE CABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE "BUNNY EARS" OF THE 30-DEGREE ENDOSCOPE PLUS WOULD NOT STAY STEADY IN EITHER 30-DEGREE UP/DOWN. A MALFUNCTIONING MECHANISM ALLOWED THE "EARS" TO FALL DURING A CASE (WITHOUT MANIPULATION FROM BEDSIDE ASSIST OR THE SURGEON AT THE CONSOLE), THEREBY CHANGING THE IMAGE ORIENTATION INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE IMAGE WAS INVERTED, AND THE ENDOSCOPE WAS MOVING WITH UNCONTROLLED MOTION. THE ENDOSCOPE WAS INSTALLED IN UP POSITION. THE SURGEON CONFIRMED THE DESIRED ORIENTATION WHEN THE ENDOSCOPE WAS INSTALLED. NO DAMAGE WAS OBSERVED AT THE BASE OF THE ENDOSCOPE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090491 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-11 N/A 00886874116555

    Patients

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