BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE

    MDR report key: 17798309 · Received September 22, 2023

    Report

    Report Number
    0001417485-2023-00002
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    August 25, 2023
    Report Date
    September 22, 2023
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    KNW
    UDI-DI
    00886333005987
    PMA / PMN Number
    K974814
    Removal / Correction Number
    1625425-09/30/2021-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE WAS AVAILABLE FOR EVALUATION. HOWEVER, IMAGES WERE PROVIDED THAT SHOWED THE DEVICES IN PIECES AND THE COMPLAINT WAS CONFIRMED. ARGON MEDICAL DEVICES HAS RECEIVED OTHER COMPLAINTS THAT THE SUPERCORE SEMI-AUTOMATIC BIOPSY INSTRUMENT IS COMING APART DURING OR PRIOR TO USE. ARGON HAS CONDUCTED AN INTERNAL INVESTIGATION AND TRACKED THE AFFECTED PARTS TO A NARROW TIME FRAME RESULTING FROM A SPECIFIC MANUFACTURING EVENT. THE PLASTIC HOUSING AND PLUNGER CAN BE SEPARATED MORE EASILY THAN NORMAL FOR THE LOTS MANUFACTURED DURING THIS TIME FRAME. CAPA C-2021-061 WAS FILED. CAPA 2021-061 HAS BEEN OPENED TO DOCUMENT OUR INVESTIGATION INTO THE CAUSE OF THIS PROBLEM AND THE CORRECTIVE ACTION THAT ARE BEING TAKEN TO ENSURE THAT THIS NEVER HAPPENS AGAIN. TO ENSURE CONTINUED CUSTOMER SATISFACTION, ARGON MEDICAL DEVICES HAS DECIDED TO ISSUE A VOLUNTARY RECALL OF THE AFFECTED LOTS BECAUSE OF THE HIGH RATE OF REPORTS OF UNINTENTIONAL DISASSEMBLY OF THESE DEVICES.

    Description of Event or Problem · 0

    THE NEEDLE SUPPORT BROKE, CAUSING DAMAGE TO THE PATIENT AND DISSATISFACTION FOR THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526748 SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE SUPERCORE KNW ARGON MEDICAL DEVICES 701218150 11406221 00886333005987

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other