BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 23353994 · Received October 21, 2025

    Report

    Report Number
    2955842-2025-41805
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    September 18, 2025
    Report Date
    November 11, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114285
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE TIPS OF THE INSTRUMENT WERE SUPPOSED TO MOVE TO THE LEFT AND THEY MOVED DOWNWARDS. THE INTENDED DIRECTION WAS SHIFTED BY 90 DEGREES. THERE WAS NO SHAKINESS AND/OR FRICTION OBSERVED. TWO INSTRUMENTS WERE REPLACED TO SOLVE THE REPORTED NON-INTUITIVE MOTION ISSUE. THE ISSUE OCCURRED WITH THE SURGEON'S HEAD INSIDE THE SURGEON SIDE CONSOLE (SSC) HIGH RESOLUTION STEREO VIEWER (HRSV) WHEN THE SURGEON WAS ATTEMPTING TO MANIPULATE THE INSTRUMENTS FROM THE SSC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT MOVEMENTS DID NOT CORRESPOND TO THE CONSOLE SURGEON. THERE WAS NON-INTUITIVE MOTION. 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 INSTRUMENT DID NOT MOVE ACCORDING TO SURGEON'S COMMANDS. NON-INTUITIVE MOTION WAS OBSERVED. IT MOVED IN AN UNINTENDED WAY OR CONTRARY TO SURGEON'S COMMANDS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613219 ENDOWRIST SP MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 430004-62 U10240918 0013 00886874114285

    Patients

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