BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI MEGA SUTURECUT NEEDLE DRIVE # 3

    MDR report key: 17602651 · Received August 23, 2023

    Report

    Report Number
    17602651
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    August 2, 2023
    Report Date
    August 2, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHILE USING DAVINCI MEGA SUTURECUT NEEDLE DRIVE # 3 (K1121106-0412) DURING SURGERY THE DEVICE BROKE AND WAS NO LONGER USABLE. HAD TO BE REPLACED WITH A DIFFERENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264165 DAVINCI MEGA SUTURECUT NEEDLE DRIVE # 3 SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 470309 K1121106-0412

    Patients

    Seq Age Sex Outcome Treatment
    1 29565 DA Male