BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 18516106 · Received January 16, 2024

    Report

    Report Number
    3001845648-2024-00027
    Event Type
    Malfunction
    Date Received
    January 16, 2024
    Date of Event
    December 18, 2023
    Report Date
    January 18, 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 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476. CANCELLATION REPORT IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION RECEIVED ON 18-JAN-2024. FDA MDR REPORTING NOT REQUIRED: NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. LOW RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 0

    NEEDLE STYLATE, NEEDLE GOT JAMMED AND SHEATH NOT RETRIEVING INSIDE SCOPE.

    Description of Event or Problem · 0

    CANCELLATION REPORT IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION RECEIVED ON 18-JAN-2024. FDA MDR REPORTING NOT REQUIRED: NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. LOW RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872851 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