BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2920257 · Received January 10, 2013

    Report

    Report Number
    1222780-2013-00011
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE EXPIRATION DATE IS NOT KNOWN. 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. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINT. 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 PHYSICIAN ATTEMPTED A NOVASURE ENDOMETRIAL ABLATION BUT COULD NOT GET THE DEVICE ARRAY TO OPEN INSIDE THE PT'S CAVITY. THE PHYSICIAN THEN PERFORMED A HYSTEROSCOPE AND "SAW THAT [THE] PT HAD A UTERINE SEPTUM". AT THIS POINT, THE PHYSICIAN RESECTED THE SEPTUM AND THE PT WAS "BLEEDING MORE THAN NORMAL" (EXACT AMOUNT UNK). THE PHYSICIAN THEN VIEWED THE CAVITY WITH A RESECTOSCOPE AND NOTED "SHE PERFORATED THE FUNDUS". THE PHYSICIAN ALSO PERFORMED A LAPAROSCOPY AND NO FURTHER DAMAGE WAS NOTED. ON (B)(6) 2013, IT WAS REPORTED THAT BLOOD LOSS WAS AT A MINIMUM. ADDITIONALLY, THE PHYSICIAN STATED THE PT WILL HEAL NATURALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15913 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNK

    Patients

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