BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEGA SUTURECUT ND

    MDR report key: 17887288 · Received October 5, 2023

    Report

    Report Number
    MW5146679
    Event Type
    Other
    Date Received
    October 5, 2023
    Date of Event
    September 22, 2023
    Report Date
    October 3, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING ROBOTIC CASE, STAFF REPORTED MEGA SUTURECUT NEEDLE DRIVER WAS NOT CUTTING EFFECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966771 MEGA SUTURECUT ND SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 471309 K10211007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown