BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOSURE REACH

    MDR report key: 13118074 · Received December 29, 2021

    Report

    Report Number
    MW5106360
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    December 27, 2021
    Report Date
    December 27, 2021
    Manufacturer
    HOLOGIC, INC.
    Product Code
    NWW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    UPON COMPLETION OF THE SURGICAL PROCEDURE, THE MYOSURE HANDPIECE WAS STUCK INSIDE THE MACHINE. A WRENCH WAS USED TO DISLODGE THE HANDPIECE OUT OF THE MACHINE. NO HARM TO PATIENT, BUT DELAYED TURNING OVER THE ROOM FOR THE NEXT CASE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013983 MYOSURE REACH HYSTEROSCOPE (AND ACCESSORIES) NWW HOLOGIC, INC. REF 10-401FC 13155702

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female