BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOSURE HOLOGIC

    MDR report key: 12540114 · Received September 27, 2021

    Report

    Report Number
    MW5104228
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    September 20, 2021
    Report Date
    September 23, 2021
    Manufacturer
    HOLOGIC, INC.
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT BOARDED FOR A HYSTEROSCOPY, DILATATION AND CURETTAGE WITH MYOSURE. DISPOSABLE MYOSURE HANDPIECE #30-401LITE, LOT #20M04R WAS DISPENSED ONTO THE STERILE FIELD. DURING PRODUCT USE IT EJECTED PLASTIC SHARDS INTO THE UTERINE CAVITY. A SECOND HANDPIECE #101-401FC, LOT # 21F17R WAS OPENED FOR USE AND FAILED IN OPERATION AS THE PLASTIC PIECES WERE CAUGHT IN THE OSCILLATING TIP. THE CAVITY WAS IRRIGATED WITH FLUID BUT IT REMAINS UNCLEAR IF ALL THE PLASTIC SHARDS WERE REMOVED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435762 MYOSURE HOLOGIC HYSTEROSCOPE (AND ACCESSORIES) HIH HOLOGIC, INC. 30-401LITE 20M04R
    1435763 MYOSURE HOLOGIC HYSTEROSCOPE (AND ACCESSORIES) HIH HOLOGIC, INC. 101-401FC 21F17R

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR