BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 22111976 · Received May 30, 2025

    Report

    Report Number
    2955842-2025-23055
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 9, 2025
    Report Date
    May 9, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114292
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS COULD NOT VERIFY THE CUSTOMER REPORTED EVENT. 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 INSTRUMENT PASSED THE CLIP TEST. THE INSTRUMENT WAS FULLY FUNCTIONAL. THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE 6 MM SINGLE PORT MEDIUM-LARGE CLIP APPLIER INSTRUMENT TO PERFORM FAILURE ANALYSIS. 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 INSTRUMENT PASSED THE CLIP TEST. THE INSTRUMENT WAS FULLY FUNCTIONAL.

    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 SURGICAL PROCEDURE, THE 6 MM SINGLE PORT MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS NOT CLIPPING. NO FRAGMENT FELL INTO THE PATIENT. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642822 ENDOWRIST SP MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 430005-57 K10230817 0005 00886874114292

    Patients

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