BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 15101989 · Received July 26, 2022

    Report

    Report Number
    3001845648-2022-00460
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Date of Event
    June 13, 2022
    Report Date
    September 19, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002520117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA 510K # K210476. REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. BASED ON ADDITIONAL INFO RECEIVED 19-SEP-22.

    Description of Event or Problem · 0

    USER TOOK THE DEVICE OUT FROM PACKAGE AND DETECTED THERE IS A BROKEN MARK ON 1.1CM FROM TIP (PR 367848) AND NEEDLE BENT (PR 367849) WHILE ADJUSTING THE NEEDLE LENGTH. NO USE ON PATIENT. USER THEN CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. N/A ¿ THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT.

    Description of Event or Problem · 0

    SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE ADDITIONAL INFORMATION RECEIVED 19-SEP-2022. PR367848 WAS OPENED FOR THE KIND (KINK) THAT OBSERVED 1.8CM FROM TIP'. THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. REPORT SUBMITTED AS CANCELLATION REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724199 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1906279 10827002520117

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Unknown