BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOUTHPIECE

    MDR report key: 10342505 · Received July 30, 2020

    Report

    Report Number
    8010047-2020-04991
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    March 24, 2020
    Report Date
    July 30, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    MNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) INVESTIGATED THE SUBJECT DEVICE AND CONFIRMED THE REPORTED PHENOMENON. A ANALYSIS REVEALED THAT THE MAIN COMPONENT OF THE BROWN SPOTS WAS THE POTASSIUM SALT OF CARBONIC ACID. OMSC SURMISED THAT FOREIGN MATERIAL MIGHT COME FROM CLEANING AGENTS AND CHEMICALS. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE DEVICE GOT BROWN SPOTS ON THE SURFACE AFTER AUTOCLAVE REPROCESSING CYCLE OLYMPUS ULTRASONIC CLEANER ENDOSONIC AND ALCOHOL WIPING COULD REMOVE THE STAINS, BUT THE STAINS APPEARED AGAIN AFTER ANOTHER AUTOCLAVE REPROCESSING CYCLE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812573 MOUTHPIECE MOUTHPIECE MNK OLYMPUS MEDICAL SYSTEMS CORP. MAJ-674 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1