BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 1061880 · Received June 18, 2008

    Report

    Report Number
    MW4000555
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 16, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IN 2008, WE HAD AN ISSUE WITH A DISPOSABLE HANDPIECE ON A CYTYC SURGICAL PRODUCTS NOVASURE SYSTEM. THE DEVICE WOULD NOT RETRACT PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE * MNB CYTYC SURGICAL PRODUCTS 09 CONTROLLER *

    Patients

    Seq Age Sex Outcome Treatment
    1 *