BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2071823 · Received April 22, 2011

    Report

    Report Number
    1222780-2011-00072
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    December 7, 2010
    Report Date
    March 23, 2011
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. SHOULD WE RECEIVE THE COMPLAINT DEVICE, A SUPPLEMENTAL MEDWATCH WITH THE RESULT OF OUR ANALYSIS WILL BE FILED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECS. 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 JUDGEMENT 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, THE FIRST NOVASURE DEVICE USED DURING AN ATTEMPTED ABLATION FAILED THE CAVITY INTEGRITY ASSESSMENT (CIA) TEST. A HYSTEROSCOPY WAS PERFORMED AND NO PERFORATION WAS NOTED. FOLLOWING A DEPLOYMENT ISSUE WITH A SECOND NOVASURE DEVICE, THE PHYSICIAN PERFORMED A REPEAT DILATATION. A UTERINE PERFORATION WAS THEN SUSPECTED AND THE NOVASURE PROCEDURE WAS ABORTED. A SMALL PERFORATION WAS CONFIRMED ON POST HYSTEROSCOPY. NO TREATMENT WAS PROVIDED AND THE PT WAS DISCHARGED. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT HAS BEEN SEEN ON FOLLOW-UP AND IS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 10B25R

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK