BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCATCH BAG

    MDR report key: 18686141 · Received February 9, 2024

    Report

    Report Number
    MW5151350
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    February 2, 2024
    Report Date
    February 7, 2024
    Manufacturer
    COVIDIEN
    Product Code
    KDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 10 MM ENDOCATCH BAG BROKE WHILE PULLING SPECIMEN OUT OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136682 ENDOCATCH BAG CONTAINER, SPECIMEN MAILER AND STORAGE, TEMPERATURE CONTROLLED, STERILE KDW COVIDIEN FEP936116B 6252109157

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male