BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20660873 · Received November 12, 2024

    Report

    Report Number
    2955842-2024-21812
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 17, 2024
    Report Date
    October 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
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT TO BE RETURNED FOR FAILURE ANALYSIS TESTING. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING IT WAS DISCOVERED THAT THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT WAS FOUND TO HAVE A BROKEN CABLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. INTUITIVE FOLLOWED UP WITH THE CUSTOMER AND WAS ADVISED THAT THERE WAS NO ADDITIONAL INFORMATION AVAILABLE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS UNKNOWN IF THERE WERE ANY ISSUE RELATED TO OPENING/CLOSING OF THE GRIPS, LEFT/RIGHT (YAW) MOTION OF THE GRIPS, UP/DOWN (PITCH) MOTION OF THE WRIST, ANY CABLES VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT. THERE WAS NO INFORMATION PROVIDED ON PATIENT-RELATED INFORMATION FROM THE INSTRUMENT¿S LAST USE. THE RELEVANT PATIENT HISTORY, INCLUDING PRE-EXISTING MEDICAL CONDITIONS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530138 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K10230727 00886874119815

    Patients

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