BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1853583 · Received September 30, 2010

    Report

    Report Number
    1222780-2010-00144
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    August 5, 2010
    Report Date
    September 1, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THIS DEVICE WAS RECEIVED IN THE LAB BENT IN SUCH A WAY THAT TESTING COULD NOT BE DONE. THE CONDITION IN WHICH IT WAS RECEIVED IS NOT CONSISTENT WITH NORMAL HANDLING AND USAGE OF THE DEVICE. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE IDENTIFIED LOT NUMBER AND SERIAL NUMBER OF THE DISPOSABLE DEVICE. NO ABNORMALITIES WERE FOUND RELATED TO THE REPORTED INFO. THIS DEVICE PASSED FINAL TESTING PRIOR TO RELEASE. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. 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

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO HOLOGIC DEVICES USED IN THE SAME PROCEDURE. SEE ASSOCIATED MEDWATCH, MANUFACTURER'S REPORT NUMBER 1222780-2010-00145. DURING AN ATTEMPTED NOVASURE ENDOMETRIAL ABLATION, THE PT SUSTAINED A PERFORATED UTERUS". A LAPAROSCOPY WAS DONE AND THE "PERFORATION REPAIRED". THE REPAIR CONSISTED OF "A RUNNING STITCH, 3RD STITCH TORE THROUGH THE UTERINE WALL, SO EDGES WERE CAUTERIZED, FLOSEAL [HEMOSTATIC MATRIX] PLACED OVER AREA AND THEN GELFOAM [HEMOSTATIC SPONGE] OVER SMALL OPENING LEFT". THE PT WAS ADMITTED TO THE HOSPITAL FOR OVERNIGHT OBSERVATION. THE PT DID WELL OVERNIGHT AND WAS DISCHARGED THE NEXT DAY ((B)(6) 2010). A HYSTEROSCOPY, DILATATION AND CURETTAGE (D&C), AND SOUNDING WERE PERFORMED PRIOR TO THE ATTEMPTED NOVASURE ABLATION. IT IS NOT KNOWN WHEN THIS PERFORATION OCCURRED OR WHAT INSTRUMENT MAY HAVE BEEN THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 10C18RA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK