BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOLOGIC MYOSURE LIGHT TISSUE REMOVAL DEVICE

    MDR report key: 20708914 · Received November 15, 2024

    Report

    Report Number
    MW5162608
    Event Type
    Other
    Date Received
    November 15, 2024
    Date of Event
    October 18, 2024
    Report Date
    November 13, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    HIH
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE 0730 CASE , MYOSURE HYSTEROSCOPY PERFORMED. WHEN USING HOLOGIC MYOSURE LIGHT TISSUE REMOVAL DEVICE MALFUNCTIONED. WHEN THE UNIT WAS PLUGGED IN THERE APPEARED TO BE NO PROBLEMS. WHEN THE PROVIDER ACTIVATED THE DEVICE THE FLUENT MACHINE READ A MESSAGE OF TORQUE TOO HIGH-LOWER CAVITY PRESSURE. THE PROVIDER HAD NOT APPLIED ANY PRESSURE. INTRA-UTERINE CAVITY PRESSURE WAS IN NORMAL LIMITS PER FLUENT MACHINE. HANDPIECE WAS REMOVED FROM PATIENT AND A NEW HANDPIECE WAS USED. NO ISSUE WITH NEW HANDPIECE. OR LEAD MADE AWARE AND ITEM BAGGED WITH ORIGINAL PACKAGING AND PLACED INTO A RED BIOHAZARD BAG. DEVICE GIVEN TO COM. PER PROVIDER NO ADVERSE EFFECTS OCCURRED TO PATIENT AS DEVICE DID NOT ACTIVATE AND A SECOND UNIT WAS READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2610231 HOLOGIC MYOSURE LIGHT TISSUE REMOVAL DEVICE HYSTEROSCOPE (AND ACCESSORIES) HIH HOLOGIC, INC. 30-401LITE 24F24RA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown