BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLOON2

    MDR report key: 10354747 · Received August 3, 2020

    Report

    Report Number
    8010047-2020-05174
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    May 12, 2020
    Report Date
    August 3, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    PMA / PMN Number
    K926514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. EVALUATION OF THE SUBJECT DEVICE CONFIRMED THE FOLLOWING; OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. BROWN SPOTS WERE ON THE SURFACE OF THE DEVICE. THE OXYGEN SCAVENGER BAG INCLUDED IN THE PACKAGE ALSO HAD BROWN SPOTS. THE BROWN SPOTS WERE RUST. OMSC ASSUMED THAT THE BROWN SPOTS ON THE DEVICE CAME FROM THE RUST ON THE OXYGEN SCAVENGER BAG. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE CUSTOMER NOTICED BROWN FOREIGN MATERIALS STUCK TO THE DEVICE ALTHOUGH THE DEVICE WAS BRAND NEW. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820857 BALLOON2 BALLOON FDF OLYMPUS MEDICAL SYSTEMS CORP. MH-303 03R

    Patients

    Seq Age Sex Outcome Treatment
    1