BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERCORE BIOPSY INSTRUMENT 18GA X 6CM

    MDR report key: 12712501 · Received October 28, 2021

    Report

    Report Number
    0001625425-2021-01110
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    October 1, 2021
    Report Date
    November 19, 2021
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    KNW
    UDI-DI
    00886333005963
    PMA / PMN Number
    K974814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE UNOPENED DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND THAT THE BODY OF THE DEVICE WAS STARTING TO SPLIT PROXIMALLY, AND THE SPRING RELEASED. THEREBY CONFIRMING THE COMPLAINT. 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 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED, AND EVALUATION IS ANTICIPATED BUT HAD NOT YET BEGUN. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN EVALUATED.

    Description of Event or Problem · 0

    SPRING POPPED OPEN AS THE NEEDLE WAS PLACED WITHIN THE NECK @ THYROID NODULE.

    Description of Event or Problem · 0

    SPRING POPPED OPEN AS THE NEEDLE WAS PLACED WITHIN THE NECK @ THYROID NODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614601 SUPERCORE BIOPSY INSTRUMENT 18GA X 6CM SUPERCORE KNW ARGON MEDICAL DEVICES 701118060 11374235 00886333005963

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other