BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1821203 · Received August 27, 2010

    Report

    Report Number
    1222780-2010-00129
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT#: 10B15RC, (B)(4), EXPIRATION DATE: 03/15/2011, MANUFACTURE DATE: 02/15/2010. ADDITIONAL INFO FOR APPROXIMATE AGE OF DEVICE: 5 MONTHS. SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER WAS NOT PROVIDED BY THE COMPLAINANT. BASED ON THE INFORMATION OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE IDENTIFIED LOT NUMBERS AND SERIAL NUMBERS OF THE DISPOSABLE DEVICES. NO ABNORMALITIES WERE FOUND RELATED TO THE REPORTED INFORMATION. THESE DEVICES PASSED FINAL TESTING PRIOR TO RELEASE. 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

    USER FACILITY REPORTED UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS USING TWO DEVICES DURING AN ATTEMPTED NOVASURE ENDOMETRIAL ABLATION. BOTH A HYSTEROSCOPY AND LAPAROSCOPY WERE PERFORMED; HOWEVER, A PERFORATION COULD NOT BE VISUALIZED. THE PATIENT WAS HOSPITALIZED AND A HYSTERECTOMY WAS PERFORMED WHICH NOTED THREE PERFORATIONS AT THE MID-LINE OF THE FUNDUS. THE PATIENT WAS DISCHARGED ON (B)(6)2010. A HYSTEROSCOPY, DILATATION AND CURETTAGE (D&C), AND SOUNDING WITH A METAL SOUND (NOT A HOLOGIC DEVICE) WERE PERFORMED PRIOR TO THE ATTEMPTED 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 10C11R

    Patients

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