BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFP FLUSHING PUMP

    MDR report key: 24203829 · Received January 28, 2026

    Report

    Report Number
    9611174-2026-00030
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    January 5, 2026
    Report Date
    January 28, 2026
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEQ
    UDI-DI
    15019778003528
    PMA / PMN Number
    K100899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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 TO OLYMPUS FOR INSPECTION. HOWEVER, TECHNICAL ASSISTANCE CENTER (TAC) PROVIDED REMOTE TROUBLESHOOTING AND LOOSE WATER BOTTLE CAP WILL NOT PRODUCE AN AIRTIGHT SEAL AND WILL PRODUCE DRIBBLING FROM THE DISTAL END OF THE SCOPE AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: LOOSE WATER BOTTLE CAP. BASED ON THE RESULTS OF THE INVESTIGATION, DUE TO RETIGHTENED THE SEAL AND THE DRIBBLING OF WATER FROM THE DISTAL TIP OF THE SCOPE STOPPED IMMEDIATELY. A DEFINITIVE ROOT CAUSE 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. TECHNICAL ASSISTANCE CENTER (TAC) PROVIDED EDUCATION VIA PHONE CALL CONFERENCE WITH THE CUSTOMER. TAC EDUCATED THE CUSTOMER THAT A LOSE OLYMPUS FLUSHING PUMP (OFP) WATER BOTTLE CAP WILL NOT PRODUCE AN AIRTIGHT SEAL AND WILL PRODUCE DRIBBLING FROM THE DISTAL END OF THE SCOPE. THE CUSTOMER STATED THE STAFF RETIGHTENED THE SEAL AND THE DRIBBLING OF WATER FROM THE DISTAL TIP OF THE SCOPE STOPPED IMMEDIATELY. TAC INFORMED THE CUSTOMER THAT THE PUMP HEAD ITEM #7502419 SHOULD BE CHANGED EVERY 12 MONTHS. TAC EMAILED THE CUSTOMER THE FOLLOWING STATEMENT: ¿THE ITEM LISTED BELOW SHOULD BE CHANGED EVERY 12 MONTHS. 7502419 (PUMP HEAD ASSEMBLY SPARE). THIS ITEM CAN BE ORDERED THROUGH OUR CUSTOMER CARE DEPT. BY CALLING 800-848-9024, OPTION 2.¿ THE ISSUE WAS RESOLVED. NO FURTHER TAC ASSISTANCE IS NEEDED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE OLYMPUS FLUSHING PUMP HAD DRIBBLING FROM THE DISTAL END DURING A DIAGNOSTIC COLONOSCOPY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265087 OFP FLUSHING PUMP OLYMPUS FLUSHING PUMP FEQ KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. 7501349 15019778003528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown