BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21176114 · Received January 17, 2025

    Report

    Report Number
    2955842-2025-00568
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 30, 2024
    Report Date
    December 30, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112342
    PMA / PMN Number
    K150284
    Removal / Correction Number
    ISIFA2024-09-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEGA NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE DISTAL END. THE COMPLAINT REGARDING A BROKEN WIRE WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) REQUESTED THAT THE MEGA NEEDLE DRIVER BE RETURNED FOR FAILURE ANALYSIS INVESTIGATION. ISI HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A WIRE ON THE MEGA NEEDLE DRIVER BROKE WHILE SUTURING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE OUT OF THE ORDINARY WAS NOTICED. THERE WERE NO INSTRUMENT COLLISIONS THAT OCCURRED DURING THE PROCEDURE. THERE WERE NO ISSUES RELATED TO THE OPENING/CLOSING, LEFT/RIGHT MOTION OF THE GRIPS, OR UP/DOWN MOTION OF THE WRIST REPORTED. THERE WERE CABLES NOTICED PROTRUDING FOR THE DEVICE. NO FRAGMENTS FELL INTO THE PATIENT. PHOTOGRAPHIC IMAGES AND THE DEVICE WERE SENT FOR ISI TO REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058730 ENDOWRIST MEGA NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 470194-08 K11240822 0152 00886874112342

    Patients

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