BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 2994056 · Received March 1, 2013

    Report

    Report Number
    2994056
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 1, 2013
    Manufacturer
    HOLOGIC, INC
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION KIT WAS OPENED FOR A PROCEDURE. THIS PRODUCT HAD A VACUUM ERROR; ATTEMPTED TO TROUBLE SHOOT AND UNABLE TO RESOLVE. OPENED ANOTHER DISPOSABLE UNIT AND IT WORKED WITHOUT ERROR. WAS NOT USED ON A PATIENT CASE AT THE TIME OF THE ERROR MESSAGE. THE STAFF WERE SETTING UP THE ROOM FOR THE CASE WHEN THE EVENT OCCURRED.======================MANUFACTURER RESPONSE FOR IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION KIT, NOVA SURE (PER SITE REPORTER).======================THEY WILL PICK UP DEVICE AND EVALUATE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88899 NOVASURE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC * 12J14RB

    Patients

    Seq Age Sex Outcome Treatment
    1 *