BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3900986 · Received June 12, 2014

    Report

    Report Number
    1222780-2014-00091
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 13, 2014
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. DEVICE HISTORY RECORD (DHR) REVIEWS WERE CONDUCTED FOR BOTH THE DISPOSABLE NOVASURE DEVICE AND RADIO FREQUENCY CONTROLLER. THE DEVICES WERE RELEASED MEETING ALL QA SPECIFICATIONS AND NO ABNORMALITIES WERE NOTED. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN PERFORMED AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2014 AND THE PATIENT WAS DISCHARGED HOME. THREE DAYS LATER, THE PATIENT PRESENTED TO THE HOSPITAL WITH A "SUDDEN ONSET OF ABDOMINAL PAIN AND WAS ADMITTED". THE PATIENT RECEIVED A COMPUTED TOMOGRAPHY (CT) SCAN WHICH "SUGGESTED SOME KIND OF PERFORATION". A LAPROSCOPY WAS PERFORMED WHICH REVEALED A THERMAL INJURY THROUGH THE "UTERINE CORNUA AND TWO AREAS ON THE SMALL BOWEL 20CM FROM ILEOCAECAL VALVE". THE PHYSICIAN REPAIRED THE INJURY LAPAROSCOPICALLY (EXACT TREATMENT UNKNOWN). ON (B)(6) 2014, IT WAS REPORTED THE PATIENT IS STILL HOSPITALIZED. SHE IS RECOVERING WELL, AND THE SURGEON EXPECTS SHE WILL BE DISCHARGED ON FRIDAY, THE (B)(6). WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348878 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC NS2000 14A07RA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R RADIO FREQUENCY CONTROLLER - SN# (B)(4)