BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4092162 · Received April 8, 2014

    Report

    Report Number
    4092162
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    February 20, 2014
    Report Date
    April 8, 2014
    Manufacturer
    OLYMPUS CORPORATION OF THE AMERICAS
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FLEXIBLE OLYMPUS URETEROSCOPE WAS REQUESTED AND OPENED FOR THE STERILE FIELD. THE SCRUB TECH EXAMINED THE SCOPE AND IT WAS DETERMINED THE TIP WAS NOT FLEXING PROPERLY. WITH FURTHER EXAMINATION THE SCRUB TECH AND SURGEON DISCOVERED SEVERAL SPOTS ALONG THE LENGTH OF THE SCOPE. WHEN THE SURGEON WIPED HIS FINGER ALONG THE SPOT, IT CAME OFF. THE SCOPE WAS IMMEDIATELY PASSED OFF THE FIELD. STERILE PROCESSING RAN A BIOBURDEN TEST WHICH CAME BACK POSITIVE. THE SCOPE WAS FOUND TO HAVE MULTIPLE LEAKS FROM VARIOUS SPOTS.======================MANUFACTURER RESPONSE FOR OLYMPUS SCOPE, OLYMPUS (PER SITE REPORTER)======================THE SCOPE HAS MULTIPLE LEAKS FROM VARIOUS DAMAGED SPOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210376 * UTEROSCOPE FGB OLYMPUS CORPORATION OF THE AMERICAS URF-V *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR