BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 25257923 · Received May 22, 2026

    Report

    Report Number
    2955842-2026-25770
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 22, 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
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS, AND THE COMPLAINT WAS CONFIRMED. 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 MEASURED APPROXIMATELY 2.76MM X 1.68MM IN SIZE. DUE TO THE BROKEN TUBE ADAPTER, A DETACHED FRAGMENT WAS OBSERVED THAT WAS NOT RETURNED WITH THE INSTRUMENT. 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 CENTRAL PROCESSING, THE SINGLE PORT MONOPOLAR CURVED SCISSORS INSTRUMENT WAS DAMAGED AT THE PLASTIC IN THE JAW. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587991 ENDOWRIST SP MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 430004-62 K11250508 0023 00886874114285

    Patients

    Seq Age Sex Outcome Treatment
    1