BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3251784 · Received July 17, 2013

    Report

    Report Number
    1222780-2013-00134
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER NOT PROVIDED BY THE COMPLAINANT. 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. 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. REFERENCE INTERNAL COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2013, THE PHYSICIAN PERFORMED A SOUNDING WITH A METAL SOUND (NOT HOLOGIC DEVICE). DURING SOUNDING THE PHYSICIAN THOUGHT HE PERFORATED AS THE SOUND WENT "TOO FAR IN". A HYSTEROSCOPY WAS PERFORMED AND NO PERFORATION WAS NOTED. THE PHYSICIAN THEN INSERTED THE DISPOSABLE DEVICE AND THE CAVITY INTEGRITY ASSESSMENT (CIA) TEST WAS UNSUCCESSFUL. ANOTHER HYSTEROSCOPY WAS PERFORMED AND A UTERINE PERFORATION WAS VISUALIZED. THE PROCEDURE WAS ABORTED AND AT THIS TIME, THE DOCTOR DECIDED TO HOSPITALIZE THE PT AND HAVE A GENERAL PHYSICIAN TAKE A LOOK AT THE PERFORATION AND DECIDE IF ANY TREATMENT SHOULD BE GIVEN. A HYSTEROSCOPY, DILATATION, AND SOUNDING WITH A METAL SOUND (NOT HOLOGIC DEVICES) WERE PERFORMED PRIOR TO THE ATTEMPTED ABLATION. IT IS NOT KNOWN WHEN THIS PERFORATION OCCURRED OR WHAT INSTRUMENT MAY HAVE BEEN THE CAUSE. WE HAVE BEEN UNABLE TO OBTAIN ADD'L INFO SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332040 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 13B25RH

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization RADIO FREQUENCY CONTROLLER: SN # UNK