BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 24173137 · Received January 24, 2026

    Report

    Report Number
    2955842-2026-02188
    Event Type
    Malfunction
    Date Received
    January 24, 2026
    Date of Event
    December 29, 2025
    Report Date
    March 13, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120286
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 30-DEGREE ENDOSCOPE PLUS FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT 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. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE: THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH MINOR CUT TO THE CABLE INSULATION. THE DAMAGE WAS LOCATED AT ZONE B IN THE MIDDLE 1/3 ON THE ENDOSCOPE CABLE. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH DAMAGE TO THE BUTTON PACK ASSEMBLY. VISUAL INSPECTION CONFIRMED HAIRLINE CRACK ON ENTER BUTTON EXHIBITING DAMAGE OF THE BUTTON PACK ASSEMBLY. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH MECHANICAL DAMAGE. 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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 8MM 30-DEGREE ENDOSCOPE PLUS HAD A BROKEN ARM CALIBRATION. THE PROCEDURE OUTCOME WAS UNKNOWN WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274455 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470067-13 N/A 00886874120286

    Patients

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