BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 23917789 · Received December 29, 2025

    Report

    Report Number
    2955842-2025-49716
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    November 4, 2025
    Report Date
    December 29, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874116562
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 0-DEGREE ENDOSCOPE PLUS WAS ANALYZED AND FOUND THE FUNCTIONAL TESTING FAILED TO PROVIDE A VIDEO DUE TO AN ELECTRICAL OR COMMUNICATION FAILURE. THE IN-HOUSE SYSTEM OR EQUIVALENT FAILED TO COMMUNICATE WITH THE ENDOSCOPE, RESULTING IN AN ERROR MESSAGE FAILED SELF-TEST. THE ENDOSCOPE WAS VISUALLY INSPECTED, AND DAMAGE WAS FOUND AT THE DISTAL END. THE DISTAL WINDOW LOCATED AT THE DISTAL TIP WAS VISUALLY INSPECTED AND FOUND TO HAVE A BROKEN OR DETACHED PIECE IN A LOCATION THAT COULD FALL INTO THE PATIENT. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH MECHANICAL DAMAGE TO THE SCOPE¿S DISTAL TIP. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND DAMAGE TO THE BUTTON PACK ASSEMBLY. A VISUAL INSPECTION CONFIRMED HAIRLINE CRACK ON L/R OF THE BUTTON PACK ASSEMBLY. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH MINOR CUT TO THE CABLE INSULATION. THE DAMAGE WAS LOCATED AT ZONE C NEAR THE ENDOSCOPE HOUSING. 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 RIGHT EYE. THE ENDOSCOPE WAS TESTED AND PLACE ON AN IN-HOUSE SYSTEM FOR CABLE TESTING AND FAILED DUE TO WAHOO PADDLEBOARD (WPB) DEFECT. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THE FAILED SELF-TEST IS ATTRIBUTED TO A FAILING COAXIAL CABLE. THE ROOT CAUSE OF THE CAMERA INSTRUMENT: DISTAL CRACKED WINDOW IS USUALLY ATTRIBUTED TO THE USER, SUCH AS INADVERTENT COLLISIONS WITH HARD SURFACES OR FALLING ENDOSCOPE OR CAUSED BY IMPROPER CLEANING DURING REPROCESSING. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO MECHANICAL DAMAGE DURING USE OR IMPROPER HANDLING, WHICH MAY INCLUDE ACCIDENTAL DROPS OF THE ENDOSCOPE. IN SOME CASES, EXTENSIVE CRACKING LEADING TO THE BUTTON PACK BREAKING OFF CAN OCCUR, WHICH IS LIKELY CAUSED BY IMPROPER CLEANING DURING REPROCESSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 0-DEGREE ENDOSCOPE PLUS WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WERE MULTIPLE FAILURES OCCURRED ON THE RIGHT EYE AND LOST THE VIDEO. THE ENDOSCOPE WAS NEVER USED IN THE CASE AND WAS REPLACED BEFORE THE PATIENT ENTERED THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2459549 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470056-05 N/A 00886874116562

    Patients

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