BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUSHING PUMP OFP-2 (US)

    MDR report key: 24291516 · Received February 9, 2026

    Report

    Report Number
    9611174-2026-00040
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 13, 2026
    Report Date
    April 29, 2026
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEQ
    UDI-DI
    15019778004716
    PMA / PMN Number
    K100899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE FOOTSWITCH OF THE OLYMPUS FLUSHING PUMP WAS NO HOLDING VACUUM. THE ISSUE WAS FOUND DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355886 FLUSHING PUMP OFP-2 (US) OLYMPUS FLUSHING PUMP FEQ KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. K10001141 15019778004716

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown