BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19768653 · Received July 18, 2024

    Report

    Report Number
    2955842-2024-17199
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    March 6, 2024
    Report Date
    June 27, 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
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. 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) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS INSPECTED PRIOR TO USE. THE ISSUE OCCURRED WHILE SUTURING. THERE WERE NO ISSUES RELATED TO OPENING/CLOSING OF THE GRIPS OR LEFT/RIGHT (YAW) MOTION OF THE GRIPS OR UP/DOWN (PITCH) MOTION OF THE WRIST. THERE WERE NOT ANY CABLES VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT. NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE WERE AVAILABLE FOR ISI REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY WITH SACROCOLPOPEXY SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT HAD SNAPPED WIRES AT THE TIP. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY USING A BACKUP INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142906 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-15 K10230720 0023 00886874119815

    Patients

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