BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT

    MDR report key: 3800016 · Received April 23, 2014

    Report

    Report Number
    3800016
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 23, 2014
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ROBOTIC ASSISTED SURGERY, THE CABLE ON THE WORKING END BROKE. THIS RESULTED IN A SLIGHT DELAY TO OBTAIN ANOTHER DEVICE. THERE WAS NO HARM TO THE PATIENT OR BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245397 MEGA SUTURECUT SYSTEM, SURGICAL, COMPUTER NAY INTUITIVE SURGICAL, INC * M10130808

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR OCCURRED DURING ROBOTIC ASSISTED SURGERY