BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)

    MDR report key: 10956810 · Received December 7, 2020

    Report

    Report Number
    8010047-2020-09909
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Report Date
    December 7, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGB
    PMA / PMN Number
    K912120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), BUT RETURNED TO OLYMPUS REPAIR CENTER FOR THE EVALUATION. THE EVALUATION OF THE DEVICE CONFIRMED THE FOLLOWINGS; COMPONENT ANALYSIS SHOWED THAT THE BROWN FOREIGN MATTER WAS RUST. OMSC GUESSED THAT THE SCREW COVER COMING OFF WAS CAUSED BY DETERIORATION OF THE ADHESIVE TO SECURE THE SCREW COVER DUE TO CHEMICAL OR PHYSICAL STRESS. THE RUST MAY HAVE BEEN CAUSED BY CORROSION OF RESIDUES SUCH AS CHEMICALS. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    A USER REPORTED THAT SOME THE PARTS OF THE DEVICE CAME OFF AND THE LEVER GOT LOOSE DURING REPROCESS. OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) AND FOUND THAT THE SCREW COVER HAD COME OFF. IT WAS ALSO FOUND THAT BROWN FOREIGN MATTERS ADHERED BETWEEN THE STOP COCK AND THE MAIN BODY. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426588 FORCEPS/IRRIGATION PLUG (ISOLATED TYPE) FORCEPS/ IRRIGATION PLUG FGB OLYMPUS MEDICAL SYSTEMS CORP. MAJ-891 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1