BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 20939931 · Received December 16, 2024

    Report

    Report Number
    3001845648-2024-00829
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 21, 2024
    Report Date
    December 19, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K210476.

    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

    SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT AS THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT (ADDITIONAL INFORMATION RECEIVED ON 19 DEC 2024 ¿ ¿CONFIRMED SCREW ISSUE WAS FROM NEEDLE LENGTH NOT SHEATH EXTENDER"). FDA MDR REPORTING NOT REQUIRED: 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)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

    Description of Event or Problem · 0

    DURING AN EBUS PUNCTURE, THE ADJUSTMENT SCREW FOR THE LOCK OF THE EBUS NEEDLE COULD NOT BE FIXED. THE CUSTOMER HAD TO USE AN OLYMPUS NEEDLE TO COMPLETE THE EXAMINATION. DURING THE EXECUTION OF AN EBUS PUNCTURE, IT WAS FOUND THAT THE LOCKING SCREW FOR THE SHEATH DID NOT WORK. IT COULD NOT BE FIXED, SO THAT THE SHEATH KEPT SLIDING BACK AND FORTH DURING THE PROCEDURE THIS SITUATION HAS ALREADY OCCURRED WITH SOME NEEDLES, BUT IT HAS NEVER BEEN REPORTED TO COOK BEFORE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2355078 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown