BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)

    MDR report key: 12906952 · Received December 1, 2021

    Report

    Report Number
    8010047-2021-15307
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    August 20, 2021
    Report Date
    December 1, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K912120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOREIGN MATERIAL CAME FROM RUST AND CHLORINE BASED ON A COMPONENT ANALYSIS. SINCE THE LOT NUMBER OF THE SUBJECT DEVICE WAS UNKNOWN, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT CONFIRM DEVICE HISTORY RECORD OF THE SUBJECT DEVICE. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS THE POSSIBILITY THAT CHLORINE COME FROM CHEMICALS THAT PROMOTE OXIDATION.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CONFIRMED THE SUBJECT DEVICE TO INVESTIGATE THE COMPLAINT. OMSC FOUND THAT THE BROWN FOREIGN MATERIAL ADHERED TO THE FITTING PART OF THE STOPCOCK WITH THE MAIN BODY. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806841 FORCEPS/IRRIGATION PLUG (ISOLATED TYPE) FORCEPS/ IRRIGATION PLUG FGB OLYMPUS MEDICAL SYSTEMS CORP. MAJ-891

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown