BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER CONTAINER (LID)

    MDR report key: 14653309 · Received June 10, 2022

    Report

    Report Number
    8010047-2022-09809
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Report Date
    August 16, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170079252
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED, AND AN INITIAL EVALUATION WAS CONDUCTED BY OLYMPUS; HOWEVER, INVESTIGATION IS ONGOING. DURING THE INITIAL EVALUATION, THE USER'S REPORT WAS CONFIRMED. THERE WAS A PHYSICAL ABNORMALITY IN THE APPEARANCE OF THE CAP. THE UNIT COULD NOT BE TESTED DUE TO THE SUSTAINED DAMAGE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE FOLLOWING THE DEVICE EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE SUBJECT DEVICE WAS MANUFACTURED IN AUGUST 2015, THOUGH A SPECIFIC DATE WAS NOT IDENTIFIED, IT HAS BEEN OVER 7 YEARS SINCE THE DEVICE WAS MANUFACTURED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. HOWEVER, THE CAUSE OF THE EVENT IS LIKELY DUE TO INAPPROPRIATE AND/OR INSUFFICIENT REPROCESSING. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: CHAPTER 5, ¿REPROCESSING¿ AND CHAPTER 6, ¿STORAGE¿. ¿IMPROPER AND/OR INCOMPLETE REPROCESSING OR STORAGE CAN PRESENT AN INFECTION CONTROL RISK, CAUSE EQUIPMENT DAMAGE OR REDUCE PERFORMANCE." IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHILE REPROCESSING HIS OLYMPUS WATER CONTAINER LID THE SURFACE OF THE WHITE CAPS ON THE WATER AND GAS BOTTLES HAD MELTED. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893290 WATER CONTAINER (LID) CAP FET OLYMPUS MEDICAL SYSTEMS CORP. MAJ-1025 58R 04953170079252

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown