BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAJ-1608 AUX. CH. WATER TUBE-PK10

    MDR report key: 24610775 · Received March 16, 2026

    Report

    Report Number
    9611174-2026-00063
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    February 12, 2026
    Report Date
    May 15, 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
    501

    Narratives

    Additional Manufacturer Narrative · 0

    E1, INITIAL REPORTER ESTABLISHMENT NAME: (B)(6) 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

    IT WAS REPORTED THAT THE OLYMPUS FLUSHING PUMP PRESENTED A CUT ON THE TUBE APPROXIMATELY 10 CM TO 15 CM AWAY FROM THE CONNECTION SECTION BETWEEN THE MAJ-1608 AND THE ENDOSCOPE, CAUSING WATER LEAKAGE FROM THE CRACK. THE ISSUE OCCURRED DURING A DIAGNOSTIC ENDOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24050 MAJ-1608 AUX. CH. WATER TUBE-PK10 OLYMPUS FLUSHING PUMP FEQ KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. K10016135

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown