BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 11596593 · Received March 31, 2021

    Report

    Report Number
    1222780-2021-00062
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    February 23, 2021
    Report Date
    May 6, 2021
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REPORTED IN CPT-5081980 WAS RECEIVED AND TESTED. UPON VISUAL INSPECTION IT WAS CONFIRMED THAT MATERIAL WAS ADHERED TO THE OUTER BOTTOM SURFACE OF THE MESH OF THE ARRAY .THE MATERIAL WAS REMOVED AND THE INTEGRITY OF THE ARRAY AND EXTERNAL SHEATH WAS INSPECTED. HOWEVER, NO OBSERVABLE DEFECTS WERE NOTED. THE MATERIAL WAS ALSO ANALYZED USING A MICROSCOPE AND IT WAS DETERMINED TO BE BIOLOGICAL TISSUE THAT GOT ADHERED TO THE MESH AS A RESULT OF THE ABLATION PROCEDURE. NO FURTHER FUNCTIONAL TESTING WAS EXECUTED. THE REPORTED OBSERVATION COULD NOT BE CONFIRMED. THIS OBSERVATION WILL BE MONITORED AND TRENDED. 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.

    Additional Manufacturer Narrative · 1

    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. NO DHR REVIEW PERFORMED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS THE LOT/SERIAL NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. OR THE PRODUCT IS NON TRACEABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON FEBRUARY 23RD, AFTER A NOVASURE PROCEDURE A VISUAL INSPECTION REVEALED FOREIGN MATERIAL ON THE MESH THAT WAS NOT PRESENT AT THE START OF THE PROCEDURE. PHYSICIAN SUSPECTED IT MIGHT HAVE MELTED FROM THE ARRAY. THE PHYSICIAN HAD TO PERFORM A HYSTEROSCOPY TO CHECK IF ANY DEBRIS WERE LEFT INSIDE THE PATIENT. THERE WERE NO DEBRIS INSIDE THE UTERUS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491065 NOVASURE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC. 2000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other