BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3251811 · Received July 18, 2013

    Report

    Report Number
    1222780-2013-00135
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 18, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE PHYSICIAN PERFORMED AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION. TWO DAYS LATER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH PAIN. THE PATIENT'S "WHITE COUNT, TEMPERATURE AND OTHER TESTS CAME BACK NORMAL" AND THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2013, THE PATIENT RETURNED TO THE EMERGENCY ROOM STILL COMPLAINING OF PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND REVEALED "FREE AIR." THE PATIENT THEN WAS TRANSFERRED TO THE OPERATING ROOM AND THERE WAS A PERFORATION AND THERMAL INJURY TO THE SMALL BOWEL. THE PHYSICIAN PERFORMED A SMALL BOWEL RESECTION AND A SUPRACERVICAL HYSTERECTOMY. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335217 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 12M18RC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention RADIO FREQUENCY CONTROLLER - SERIAL # UNK