BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 21800907 · Received April 8, 2025

    Report

    Report Number
    2955842-2025-13935
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 4, 2024
    Report Date
    March 13, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE SINGLE-PORT (SP) ROUND TOOTH RETRACTOR (RTR) INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED, AND THE COMPLAINT COULD NOT BE REPLICATED NOR CONFIRMED. THE INSTRUMENT WAS TESTED ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIP TIPS OPENED AND CLOSED PROPERLY. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS RESULTS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE INSTRUMENT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, SINGLE-PORT (SP) ROUND TOOTH RETRACTOR (RTR) INSTRUMENT MOVED NON-INTUITIVELY. NO FRAGMENT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740957 ENDOWRIST SP ROUND TOOTH RETRACTOR NAY INTUITIVE SURGICAL, INC 430002-57 U10220512 0020

    Patients

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