BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 9344107 · Received November 19, 2019

    Report

    Report Number
    1222780-2019-00260
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    October 30, 2019
    Report Date
    October 30, 2019
    Manufacturer
    HOLOGIC, INC
    Product Code
    MNB
    UDI-DI
    45420045501127
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF THE DEVICE IS RETURNED AND EVALUATION COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED IDENTIFICATION NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE EAP LIGHT WOULD NOT EXTINGUISH. THE DOCTOR REMOVED THE DEVICE FROM THE CAVITY AND THE EAP LIGHT WOULD STILL NOT GO OUT. THE DOCTOR VIEWED THE UTERUS LAPAROSCOPICALLY AND VIEWED A PERFORATION AT THE FUNDUS. NO TREATMENT WAS GIVEN TO PATIENT. NO ADDITIONAL DETAILS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139513 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC, INC NS2013 19J02R 45420045501127

    Patients

    Seq Age Sex Outcome Treatment
    1 Other