BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLER EA SYSTEM

    MDR report key: 3925625 · Received June 27, 2014

    Report

    Report Number
    1222780-2014-00105
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 30, 2014
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE EXPIRATION DATE IS NOT KNOWN. SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER NOT PROVIDED BY THE COMPLAINANT. THE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE MFR DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WARNINGS: USE CAUTION NOT THE PERFORATE THE UTERINE WALL WHEN SOUNDING, DILATING, OR INSERTING THE DISPOSABLE DEVICE. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO HOLOGIC DEVICES USED IN THE SAME PROCEDURE. SEE ASSOCIATED MEDWATCH, MFR'S REPORT #1222780-2014-00104. IT WAS REPORTED THAT PRIOR TO A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2014, THE PHYSICIAN PERFORMED A HYSTEROSCOPY AND NOTED A UTERINE PERFORATION (LOCATION UNK). THE PHYSICIAN DECIDED TO CONTINUE ON AND TO ATTEMPT THE NOVASURE PROCEDURE. REPORTEDLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO MEDICAL INTERVENTION OR TREATMENT REQUIRED. THE PT WAS DISCHARGED HOME AND IS "DOING OK". A HYSTEROSCOPY AND DILATION, (NOT HOLOGIC DEVICES) WERE PERFORMED PRIOR TO THE ABLATION. IT IS NOT KNOW WHEN THIS PERFORATION OCCURRED OR WHAT INSTRUMENT MAY HAVE BEEN THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376775 NOVASURE IMPEDANCE CONTROLLER EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK