BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 7166971 · Received January 5, 2018

    Report

    Report Number
    3001845648-2018-00004
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Date of Event
    December 6, 2017
    Report Date
    February 28, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002347854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K142688. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K142688. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). INVESTIGATION IS PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K142688. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL MDR REPORT. A CONSERVATIVE APPROACH WAS TAKEN IN INITIALLY ASSESSING THIS COMPLAINT. AFTER DEVICE EVALUATION 07-MAR-18 CONFIRMING: NO NEEDLE EXPOSURE, NO RETRACTION/ ADVANCEMENT ISSUES, NO ISSUE NOTED WITH EITHER LOCK/ SHEATH ADJUSTER, NO ISSUES WITH THE NEEDLE TIP, STYLET CAN BE INSERTED/ REINSERTED WITH EASE, SLIGHT CRACK AT SHEATH THUMBSCREW- SHEATH ADJUSTER SLIPPING. THIS EVENT DOES NOT MEET THE FDA MDR REPORTING CRITERIA.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K142688 (B)(4). EXEMPTION NUMBER: E2016031 (B)(4) INVESTIGATION IS PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    WHILE USING THE NEEDLE, THE NEEDLE LOCK DID NOT FIT PROPERLY IN ITS PLACE.

    Description of Event or Problem · 0

    WHILE USING THE NEEDLE, THE NEEDLE LOCK DID NOT FIT PROPERLY IN ITS PLACE.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT. DEVICE WAS EVALUATED THE 07-MAR-18 CONFIRMING: NO NEEDLE EXPOSURE, NO RETRACTION/ ADVANCEMENT ISSUES, NO ISSUE NOTED WITH EITHER LOCK/ SHEATH ADJUSTER, NO ISSUES WITH THE NEEDLE TIP, STYLET CAN BE INSERTED/ REINSERTED WITH EASE, SLIGHT CRACK AT SHEATH THUMBSCREW- SHEATH ADJUSTER SLIPPING. 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 WAS SUBMITTED BASED ON CONSERVATIVE ASSUMPTION THE NEEDLE LOCK WAS THE ISSUE NOT THE SHEATH LOCK AS LATER CONFIRMED.

    Description of Event or Problem · 0

    WHILE USING THE NEEDLE, THE NEEDLE LOCK DID NOT FIT PROPERLY IN ITS PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11209 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G34785 00827002347854

    Patients

    Seq Age Sex Outcome Treatment
    1