BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19226655 · Received May 1, 2024

    Report

    Report Number
    2955842-2024-13949
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 8, 2024
    Report Date
    April 8, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT INVOLVED WITH THIS COMPLAINT, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND REPORTED FAILURE WAS NOT CONFIRMED. VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN 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 GRIPS OPENED AND CLOSED PROPERLY. THE GRIPS WERE ALIGNED. THE INSTRUMENT PASSED THE SUTURE TEST ON 3 OF 3 ATTEMPTS. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT DOES NOT ARTICULATE CORRECTLY (NON-INTUITIVE MOTION). THE PROCEDURE WAS COMPLETED. NO KNOWN IMPACT TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039452 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K12231109 0003 00886874119815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES