BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3981480 · Received July 25, 2014

    Report

    Report Number
    1222780-2014-00121
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO BE REPORTED OBSERVATION. REFERENCE INTERNAL COMPLAINT CC# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN PERFORMED A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2014 AND RECEIVED AN UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TEST. A HYSTEROSCOPY WAS PERFORMED AND A "PIN-HOLE PERFORATION" WAS VISUALIZED. THE ATTEMPTED NOVASURE WAS ABORTED. NO INTERVENTION WAS REQUIRED AND THE PT WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436618 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC NS2000 13M07R

    Patients

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