BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCON ACMI

    MDR report key: 3731813 · Received April 2, 2014

    Report

    Report Number
    MW5035472
    Event Type
    Injury
    Date Received
    April 2, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 1, 2014
    Manufacturer
    OLYMPUS
    Product Code
    FBO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAVING A CYSTO URETHROGRAM WHEN THE TIP OF THE OBTURATOR SHEATH BROKE OFF AND HAD TO BE RETRIEVED FROM THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199938 CIRCON ACMI CIRCON ACMI OBTURATOR SHEATH FBO OLYMPUS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention