BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 22331951 · Received June 25, 2025

    Report

    Report Number
    2955842-2025-27402
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 27, 2025
    Report Date
    May 27, 2025
    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
    OH, 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 (FA). 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. THERE WAS NO MATERIAL MISSING AS A RESULT OF THE BREAK. ADDITIONAL OBSERVATION(S) NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE A BROKEN DISTAL MAIN TUBE. NO MATERIAL WAS FOUND MISSING. COMPONENTS ADJACENT TO THIS BROKEN MAIN TUBE DO NOT SHOW DAMAGE. THE COMPLAINT 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 PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE PORT MONOPOLAR CAUTERY INSTRUMENT WAS FOUND TO HAVE A BROKEN TIP. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142783 ENDOWRIST SP MONOPOLAR CAUTERY INSTRUMENT NAY INTUITIVE SURGICAL, INC 430007-57 U10230207 0005 00886874114315

    Patients

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