BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20288594 · Received September 24, 2024

    Report

    Report Number
    2955842-2024-19843
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    January 3, 2024
    Report Date
    August 30, 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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, FAILURE ANALYSIS OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE INSTRUMENT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED MEDWATCH REPORT# MW5158270 STATING: THE 8MM MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT'S CABLE BROKE. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED DURING GENERAL SURGERY AND THERE WERE NO ISSUES RELATED TO OPENING/CLOSING OF THE GRIPS. THERE WERE 2 CABLES VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT: ONE THAT CONTROLS OPENING/CLOSING OF THE JAWS AND ONE THAT CONTROLS UP/DOWN MOTION OF THE WRIST. NO FRAGMENT FELL INSIDE OF THE PATIENT¿S ANATOMY AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290981 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K11230810 00886874119815

    Patients

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