BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOSURE HOLOGIC

    MDR report key: 18777349 · Received February 23, 2024

    Report

    Report Number
    MW5151900
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    January 31, 2024
    Report Date
    February 12, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(4) DURING A HYSTEROSCOPY WE WERE ATTEMPTING TO USE THE MYOSURE LITE HANDPIECE. THIS IS A DISPOSABLE HANDPIECE THAT HOOKS INTO THE MYOSURE MACHINE. ONCE HOOKED UP, THE SURGEON STARTED TO USE IT AND IT WAS MAKING A LOUD CRANKING NOISE LIKE IT WAS BOGGED DOWN INSIDE THE CORD. ANOTHER DEVICE WAS RETRIEVED AND IT DID THE SAME THING. PRODUCT FAILURE ON HANDPIECE. RETRIEVED A SECOND HANDPIECE AND HAD THE SAME ISSUE. NO HARM TO PATIENT. SURGEON FINISHED CASE USING CURETTES. SERVICE REP NOTIFIED AND WILL PICK UP DEFECTIVE DEVICES. LAST PREVENTATIVE MAINTENANCE ON MYOSURE MACHINE WAS 3/2023. NEXT PM DUE 2/2024 BY CLINICAL ENGINEERING. MYOSURE HOLOGIC (B)(4). REFERENCE REPORTS: MW5151899, MW5151901.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539035 MYOSURE HOLOGIC HYSTEROSCOPE (AND ACCESSORIES) HIH HOLOGIC, INC. 30-401LITE

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other