BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUSHING PUMP OFP-2 (JP)

    MDR report key: 24317283 · Received February 11, 2026

    Report

    Report Number
    9611174-2026-00044
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 20, 2026
    Report Date
    March 23, 2026
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEQ
    PMA / PMN Number
    K100899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, D9, H2, H3, H6, H11. THE DEVICE WAS RETURNED FOR INSPECTION AND THE CUSTOMER'S ALLEGATION WAS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION IT IS LIKELY THAT THE EVENT REPORTED IS CAUSED BY A COMPONENT FAILURE OF THE DEFOGGING FUNCTION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLUSHING PUMP EXHIBITED A WATER LEAKAGE DURING SERVICE AND MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57908 FLUSHING PUMP OFP-2 (JP) OLYMPUS FLUSHING PUMP FEQ KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. K10001142

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown