BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 24374303 · Received February 18, 2026

    Report

    Report Number
    2955842-2026-04746
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    January 12, 2026
    Report Date
    February 17, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114315
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SINGLE PORT MONOPOLAR CAUTERY INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN INSTRUMENT 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 WAS NOT RETURNED AND MEASURES APPROXIMATELY 0.80M X 2.31MM IN SIZE. ADDITIONAL COMMON CAUSES INCLUDE IMPROPER INSTALLATION OR REMOVAL OF THE TIP ACCESSORY. E A DETACHED FRAGMENT. THE FRAGMENT BROKE OFF FROM THE INSTRUMENTS TUBE ADAPTER AND WAS NOT RETURNED WITH THE INSTRUMENT. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO USE CONDITIONS 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 THE SINGLE PORT MONOPOLAR CAUTERY INSTRUMENT HAD A BROKEN TIP AND IT COULD NOT BE INSTALLED. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. 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
    438690 ENDOWRIST SP MONOPOLAR CAUTERY INSTRUMENT NAY INTUITIVE SURGICAL, INC 430007-62 K10250619 0001 00886874114315

    Patients

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