BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18656670 · Received February 7, 2024

    Report

    Report Number
    2955842-2024-11108
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    January 15, 2024
    Report Date
    January 17, 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
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MEGA SUTURECUT NEELD DRIVER INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE MEGA SUTURECUT NEELD DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE DISTAL END. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUE. THERE WAS NO INSTRUMENT DAMAGE OR INSTRUMENT COLLIDING WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THERE WERE NO ISSUES WITH OPENING/CLOSING, LEFT/RIGHT MOTION OF THE GRIPS, LEFT/RIGHT MOTION, OR UP/DOWN MOTION OF THE GRIPS. THERE ARE PROTRUDING CABLE(S) BUT UNKNOWN IF IT CONTROLS UP/DOWN MOTION. THERE WAS NO FRAGMENT FALLING INSIDE THE PATIENT'S ANATOMY. NO IMAGE IS AVAILABLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT HAD A BROKEN EXPOSED WIRE DURING USAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    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
    1792797 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K11230914 0461 00886874119815

    Patients

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