BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAJ-1682 ACCESSORY PORT TUBE WITH SALINE SPIKE - PK 10

    MDR report key: 24918180 · Received April 17, 2026

    Report

    Report Number
    9611174-2026-00083
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    January 23, 2026
    Report Date
    May 11, 2026
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEQ
    PMA / PMN Number
    K000948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, A 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.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE ACCESSORY PORT TUBE EXHIBITED TUBE TORN OFF AT THE ENDO THERAPY ACCESSORY SIDE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69201 MAJ-1682 ACCESSORY PORT TUBE WITH SALINE SPIKE - PK 10 OLYMPUS FLUSHING PUMP FEQ KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. K10026686

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown