BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE

    MDR report key: 17949270 · Received October 17, 2023

    Report

    Report Number
    0001417485-2023-00007
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    September 29, 2023
    Report Date
    August 31, 2024
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    KNW
    UDI-DI
    00886333006045
    PMA / PMN Number
    K974814
    Removal / Correction Number
    1625425-09/30/2021-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.

    Additional Manufacturer Narrative · 0

    SAMPLE IS INDICATED AS RETURNED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY.

    Additional Manufacturer Narrative · 0

    AFTER PERFORMING A SEARCH OF OUR COMPLAINT DATABASE FOR REPORTS OF SIMILAR CONDITIONS IT HAS BEEN DETERMINED THAT THE NONCOMPLIANCE REPORTED HAS BEEN EXPERIENCED BY OTHER CUSTOMERS AS WELL. SINCE THE PRODUCTION OF LOT 11416767 CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED PER CAPA C-2021-061.

    Description of Event or Problem · 0

    WHEN RESETTING THE BIOPSY NEEDLE, THE HANDLE FAILED AT THE SPRING, MAKING IT IMPOSSIBLE TO REENGAGE THE NEEDLE TO PERFORM A SECOND BIOPSY. INCREASED DURATION OF THE PROCEDURE / PAIN FOR THE PATIENT.

    Description of Event or Problem · 0

    WHEN RESETTING THE BIOPSY NEEDLE, THE HANDLE FAILED AT THE SPRING, MAKING IT IMPOSSIBLE TO REENGAGE THE NEEDLE TO PERFORM A SECOND BIOPSY. INCREASED DURATION OF THE PROCEDURE / PAIN FOR THE PATIENT.

    Description of Event or Problem · 0

    WHEN RESETTING THE BIOPSY NEEDLE, THE HANDLE FAILED AT THE SPRING, MAKING IT IMPOSSIBLE TO REENGAGE THE NEEDLE TO PERFORM A SECOND BIOPSY. INCREASED DURATION OF THE PROCEDURE/PAIN FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94459 SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE SUPERCORE KNW ARGON MEDICAL DEVICES 701218090 11416767 00886333006045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other