BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 24724974 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-19743
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 10, 2026
    Report Date
    March 29, 2026
    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
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SINGLE PORT MONOPOLAR CURVED SCISSORS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN TUBE ADAPTER. THIS COMPONENT WAS LOCATED AT THE DISTAL END OF THE INSTRUMENT AND SERVES AS THE INTERFACE BETWEEN THE INSTRUMENT AND THE USER INSTALLED TIP ACCESSORY. THE BROKEN PIECE, MEASURING APPROXIMATELY 1.8MM X 2.2MM WAS NOT RETURNED WITH THE INSTRUMENT. THE INSTRUMENT WAS TESTED FOR ELECTRICAL CONTINUITY AND PASSED WHEN TESTING FOR THE INSTRUMENT TIP, ENERGY BOARD AND CAUTERY WIRE. THE INSTRUMENT COULD NOT BE TESTED ON THE IN-HOUSE SYSTEM DUE TO THE BROKEN TUBE ADAPTER; THEREFORE, THE FUNCTIONAL TEST COULD NOT BE PERFORMED. VISUAL INSPECTION WAS PERFORMED AND THERE WAS NO DAMAGE TO THE SNAKE WRIST CABLES, HOUSING AND SHAFT. THE PROBABLE ROOT CAUSE OF A DAMAGED TUBE ADAPTER IS ATTRIBUTED TO EITHER TIP ACCESSORY INSTALLATION ISSUES OR DAMAGE DURING USE. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE INSTRUMENT TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    THE SINGLE PORT MONOPOLAR CURVED SCISSORS INSTRUMENT WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI). NO ADDITIONAL INFORMATION WAS PROVIDED. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER BUT WAS UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257372 ENDOWRIST SP MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 430004-53 S10200123 0002 00886874114285

    Patients

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