BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRA

    MDR report key: 20722572 · Received November 19, 2024

    Report

    Report Number
    3005099803-2024-05793
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 28, 2024
    Report Date
    November 19, 2024
    Manufacturer
    JIANGSU JIANYU HEALTH MEDICAL CO LTD
    Product Code
    FEQ
    UDI-DI
    00840253108425
    PMA / PMN Number
    K161482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A140507, CAPTURES THE REPORTABLE EVENT OF REFLUX WITHIN DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, TO BOSTON SCIENTIFIC CORPORATION. THAT HYDRA IRRIGATION TUBING WAS USED IN THE COLON, DURING A COLONOSCOPY PROCEDURE. PERFORMED FOR SCREENING ON (B)(6) 2024. DURING THE PROCEDURE, BACKFLOW OF BLOOD COLORED FLUID INTO THE IRRIGATION TUBE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED, THAT THE CUSTOMER CONNECTED THE ENDOWASHER DIRECTLY TO THE LUER CONNECTOR OF THE IRRIGATION CHANNEL OF THE ENDOSCOPE. HOWEVER, THE HYDRA INSTRUCTIONS FOR USE (IFU) STATE, TO CONNECT THE IRRIGATION TUBING, THE APPROPRIATE IRRIGATION SCOPE CONNECTOR THAT IS ATTACHED TO THE AUXILIARY WATER JET PORT. THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57153 HYDRA PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE FEQ JIANGSU JIANYU HEALTH MEDICAL CO LTD SIT-575-15 0000231225 00840253108425

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown