BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 18901149 · Received March 14, 2024

    Report

    Report Number
    3001845648-2024-00093
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Report Date
    April 17, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002342818
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476. THIS CANCELLATION REPORT IS BEING SUBMITTED DUE TO CONFIRMATION OF CANCELLATION AGREED WITH QUALITY ENGINEERING ON THE (B)(6) 2024 DUE TO ADDITIONAL INFORMATION RECEIVED ON 15-FEB-2024 - USE OF FUJI SCOPE CONFIRMED - TO BE CAPTURED IN PR (B)(4). (MDR REFERENCE NUMBER 3001845648-2024-00027): TO UPDATE TO REPORTED, USED: 10 IN PR (B)(4).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THIS CANCELLATION REPORT IS BEING SUBMITTED DUE TO CONFIRMATION OF CANCELLATION AGREED WITH QUALITY ENGINEERING ON THE (B)(6) 2024 DUE TO ADDITIONAL INFORMATION RECEIVED ON 15-FEB-2024 - USE OF FUJI SCOPE CONFIRMED - TO BE CAPTURED IN PR (B)(4). (MDR REFERENCE NUMBER 3001845648-2024-00027): TO UPDATE TO REPORTED, USED: 10 IN PR (B)(4).

    Description of Event or Problem · 0

    NEEDLE STYLATE, NEEDLE GOT JAMMED AND SHEATH NOT RETRIEVING INSIDE SCOPE (ORIGINAL PR (B)(4) - MDR~3001845648-2024-00027). CONFIRMED ON 15 FEB 2024 THAT THE SAME ISSUE OCCURRED ON 5 DIFFERENT PATIENTS IN TOTAL SO THIS COMPLAINT WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968459 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C2030823 10827002342818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown