BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE CONTROLLER

    MDR report key: 13237378 · Received January 12, 2022

    Report

    Report Number
    1222780-2022-00027
    Event Type
    Injury
    Date Received
    January 12, 2022
    Date of Event
    June 14, 2021
    Report Date
    February 2, 2022
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT/SERIAL NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. WE ARE CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

    Additional Manufacturer Narrative · 0

    THE NOVASURE RFC SYSTEM WAS EVALUATED BY MANUFACTURING OPERATIONS ON (B)(6) 2022. THE UNIT WAS RETURNED DUE TO BEING INVOLVED WITH A POTENTIAL ADVERSE EVENT AND WAS SUBJECTED TO THE FINAL SERVICE INSPECTION TESTING. THERE WERE NO OBVIOUS SIGNS OF DAMAGE OR MISUSE REPORTED FOLLOWING A VISUAL INSPECTION OF THE UNIT. THE RFC DEVICE PASSED ALL FINAL INSPECTION TESTS AND HIGH POTENTIAL ELECTRICAL SAFETY TESTING. THERE WAS NO FAULT OBSERVED ON THE RETURNED SYSTEM. THE REPORTED COMPLAINT HAS BEEN NOT CONFIRMED AT THIS TIME, IT IS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE OF THE REPORTED COMPLAINT. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THIS SERIAL NUMBER, THE DEVICE WAS RELEASED MEETING ALL INSPECTION CRITERIA. HOLOGIC WILL CONTINUE TO TRACK AND TREND THIS FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2021 A RFC CONTROLLER WAS INVOLVED IN A PROCEDURE IN WHICH PATIENT HARM WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738343 NOVASURE CONTROLLER DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC. RFC2010

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other NOVASURE DISPOSABLE