BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1831957 · Received September 8, 2010

    Report

    Report Number
    1222780-2010-00137
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 12, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE EXP DATE OF THE NOVASURE DISPOSABLE DEVICE IS NOT KNOWN. THE NOVASURE DISPOSABLE DEVICE WAS NOT RETURNED; HOWEVER, THE RADIO FREQUENCY CONTROLLER HAS BEEN RECEIVED. THE FAILURE ANALYSIS HAS BEEN COMPLETED FOR THE RADIO FREQUENCY CONTROLLER. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE MANUFACTURE DATE OF THE DISPOSABLE DEVICE IS UNK. THE INFO CONTAINED IN THIS FIELD IS THE MANUFACTURE DATE OF THE RADIO FREQUENCY CONTROLLER. THE RADIO FREQUENCY CONTROLLER PASSED ALL FUNCTIONAL AND ELECTRICAL TESTING. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE AS A LOT AND SERIAL NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE RADIO FREQUENCY CONTROLLER (CSP 4478). THERE WERE NO REWORKS OR OBSERVATIONS NOTED AT THE TIME OF MANUFACTURE. NO RELATIONSHIP CAN BE ESTABLISHED BETWEEN DHR AND CURRENT COMPLAINT. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNEVENTFUL NOVASURE PROCEDURE, OCCURRED APPROX (B)(6), 2010. ON (B)(6) 2010, THE PT WAS SEEN IN THE EMERGENCY ROOM WITH "ABDOMINAL PAIN". THE PT WAS ADMITTED AND EXPLORATORY SURGERY WAS PERFORMED DURING WHICH A TUBAL OVARIAN ABSCESS WAS NOTED. THE PHYSICIAN REMOVED THE PT'S RIGHT OVARY AND FALLOPIAN TUBE AND PLACED THE PT ON ANTIBIOTICS. THE PT WAS DISCHARGED ON (B)(6) 2010 AND WAS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R RADIO FREQUENCY CONTROLLER - SERIAL NUMBER (B)(4)