BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 24142029 · Received January 22, 2026

    Report

    Report Number
    2955842-2026-01849
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    December 29, 2025
    Report Date
    January 21, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SINGLE PORT MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN INSTRUMENT TUBE ADAPTER. THIS COMPONENT IS 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 WAS NOT RETURNED AND WOULD HAVE MEASURED APPROXIMATELY 2.08MM X 1.74MM. THE BROKEN TIP ADAPTER MADE IT DIFFICULT TO INSTALL A TIP AND CAUSED THE TIP TO NOT BE SECURELY ATTACHED. THE PROBABLE ROOT CAUSE OF A DAMAGED TUBE ADAPTER IS ATTRIBUTED TO EITHER TIP ACCESSORY INSTALLATION ISSUES OR DAMAGE DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE SINGLE PORT MONOPOLAR CURVED SCISSORS INSTRUMENT COULD NOT BE LOADED. THE DISTAL END WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203657 ENDOWRIST SP MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 430004-57 U10230720 0009 00886874114285

    Patients

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