BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 14117008 · Received April 15, 2022

    Report

    Report Number
    3001845648-2022-00228
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    March 16, 2022
    Report Date
    October 17, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002347851
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K142688. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K142688. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    CANCELLATION REPORT SUBMITTED AS THE INVESTIGATION PROVED A COOK DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 0

    USER CHECKED THE TARGET AREA AFTER BIOPSY AND FOUND OUT THERE WAS A BROKEN NEEDLE TIP INSIDE PATIENT. USER SUSPECTED THE BROKEN NEEDLE WAS STUCK INSIDE THE SHEATH DURING BIOPSY.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED BECAUSE COMPLAINT DEVICE WAS RETURNED AND EVALUATED ON 11-JUL-2022: VISUAL INSPECTION: - BROKEN NEEDLE TIP RETURNED SEPARATELY (APPROX. 2.4CM IN LENGTH) - DISTAL END OF NEEDLE EXAMINED AND NO ISSUE OBSERVED - PROXIMAL KINK BELOW THE SHEATH EXTENDER OBSERVED - EVIDENCE OF BLOOD ON DISTAL END OF NEEDLE. - MLLA EXAMINED AND OBSERVED TO BE OFF-CENTER. FUNCTIONAL INSPECTION: - SHEATH EXTENDER ABLE TO RETRACT WITH DIFFICULTY AND UNABLE TO ADVANCE. - NEEDLE ABLE TO ADVANCE WITH A LOT OF DIFFICULTY - RETRACTED NEEDLE HANDLE BUT DISTAL END OF NEEDLE DID NOT RETRACT INTO THE SHEATH. - NEEDLE REMOVED FROM DEVICE AND NEEDLE BREAK OBSERVED APPROXIMATELY 98CM FROM BASE OF NEEDLE HUB. - DIAMETER OF BROKEN NEEDLE TIP WHICH WAS RETURNED SEPARATELY WAS MEASURED, DIMENSION 0.042 INCHES - DIAMETER OF DISTAL END OF NEEDLE FROM DEVICE RETURNED MEASURED, DIMENSION 0.036 INCHES.

    Description of Event or Problem · 0

    CANCELLATION REPORT BEING SUBMITTED DUE TO ADDITIONAL INFORMATION RECEIVED CONFIRMING A COOK DEVICE WAS NOT THE COMPLAINT DEVICE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138104 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1665755 10827002347851

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention