BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 24225348 · Received January 30, 2026

    Report

    Report Number
    2955842-2026-02823
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    September 26, 2025
    Report Date
    January 30, 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
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS ANALYZED AND 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 2.53MM X 1.81MM IN SIZE. THE BROKEN TIP ADAPTER MADE IT DIFFICULT TO INSTALL A TIP AND CAUSED THE TIP TO NOT BE SECURELY ATTACHED. VISUAL INSPECTION WAS PERFORMED AND FOUND NO EXTERNAL DAMAGE TO THE SHAFT. THE COMPLAINT REGARDING THE TIP IS BROKEN, WAS CONFIRMED BY FAILURE ANALYSIS. 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 DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: INSTRUMENT WAS TAGGED WITH A BROKEN TAG. CUSTOMER CHECKED THE TIP, AND IT WAS CRACKED AND WAS NOT SURE IF A PIECE WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287924 ENDOWRIST SP MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 430004-62 K10250313 0025 00886874114285

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES