BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 4251773 · Received November 6, 2014

    Report

    Report Number
    1222780-2014-00191
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS. 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. 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. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WARNINGS: USE CAUTION NOT TO PERFORATE THE UTERINE WALL WHEN SOUNDING, DILATING, OR INSERTING THE DISPOSABLE DEVICE. IF THE DISPOSABLE DEVICE IS DIFFICULT TO INSERT INTO THE CERVICAL CANAL, USE CLINICAL JUDGMENT TO DETERMINE WHETHER OR NOT FURTHER DILATION IS REQUIRED. THE NOVASURE SYSTEM PERFORMS A CAVITY INTEGRITY ASSESSMENT (CIA) TEST TO EVALUATE THE INTEGRITY OF THE UTERINE CAVITY, AND SOUNDS AN ALARM WARNING OF A POSSIBLE PERFORATION PRIOR TO TREATMENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN PERFORMED A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2014. THE PHYSICIAN HAD DIFFICULTY SEATING THE DISPOSABLE ELECTRODE ARRAY INSIDE THE PT. THE PHYSICIAN THEN RECEIVED A "FEW" UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS. THE ATTEMPTED PROCEDURE WAS ABORTED. THE PHYSICIAN PERFORMED A HYSTEROSCOPY AND "FOUND A FUNDAL PERFORATION". IT IS UNK IF INTERVENTION WAS REQUIRED. ON (B)(6) 2014, IT WAS REPORTED THE "PERFORATION WAS ON THE POSTERIOR PORTION OF THE WALL AND THE PT IS DOING WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714179 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC NS2000 14B12R

    Patients

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