BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE PRO GI

    MDR report key: 7732629 · Received July 30, 2018

    Report

    Report Number
    3005099803-2018-02481
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Report Date
    October 1, 2018
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE 29 EVENTS REPORTED UNDER EXEMPTION NUMBER E2012013, 22 COMPLAINT DEVICES WERE RETURNED AND 7 COMPLAINT DEVICES WERE NOT RETURNED. 12 EVENTS WERE FOUND TO HAVE A ROOT CAUSE OF OPERATIONAL CONTEXT, 8 EVENTS WERE FOUND TO HAVE A ROOT CAUSE OF SUPPLIER DESIGN, AND 2 EVENTS WERE FOUND TO HAVE A ROOT CAUSE OF USER ERROR. CONCLUSION CODE 4316 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR "DEVICE NOT RETURNED" FOR ALL RELEVANT EVENTS.

    Additional Manufacturer Narrative · 1

    EXEMPTION E2012013_SUBMISSION_KNQ.

    Description of Event or Problem · 1

    THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2012013 FOR PRODUCT CODE KNQ. THIS REPORT COVERS 29 REPORTED EVENTS OF BALLOONS BURSTS/PINHOLES. OF THE EVENTS, 3 PATIENTS WERE FEMALE AND 6 WERE MALE. THE KNOWN PATIENTS' AGES RANGED FROM 38 YEARS TO 87 YEARS. THE KNOWN PATIENTS' WEIGHTS RANGED FROM 60 KG TO 68 KG. ALL OTHER DEMOGRAPHIC INFORMATION IS UNKNOWN.

    Description of Event or Problem · 1

    THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2012013 FOR PRODUCT CODE KNQ. QUARTERLY SUBMISSION DUE OCTOBER 31, 2018. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR 1 EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573123 CRE PRO GI DILATOR, ESOPHAGEAL KNQ M00558790

    Patients

    Seq Age Sex Outcome Treatment
    1