BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERCORE BIOPSY INSTRUMENT 18GA X 6CM

    MDR report key: 17564607 · Received August 17, 2023

    Report

    Report Number
    0001625425-2023-01159
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    May 2, 2023
    Report Date
    August 29, 2023
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    KNW
    UDI-DI
    00886333005963
    PMA / PMN Number
    K974814
    Removal / Correction Number
    1625425-09/30/2021-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Additional Manufacturer Narrative · 0

    NO SAMPLE WAS AVAILABLE FOR EVALUATION. 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 ACTIONS THAT ARE BEING TAKEN.

    Description of Event or Problem · 0

    DESCRIBE THE EVENT OR PROBLEM: THE RADIOLOGIST WAS DOING A PROCEDURE ON THE PATIENT'S LEFT SHOULDER. WHEN SHE PULLED THE DEVICE FROM THE PATIENT AFTER TAKING A PASS CONTAINING A SPECIMEN THE DEVICE DISASSEMBLED FALLING APART IN THE RADIOLOGIST HANDS. SHE WAS ALMOST PUNCTURED WITH THE BLADE FROM THE DEVICE. DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING); DEVICE WAS HARD TO USE;

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791239 SUPERCORE BIOPSY INSTRUMENT 18GA X 6CM SUPERCORE KNW ARGON MEDICAL DEVICES 701118060 11461554 00886333005963

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other