BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERCORE BIOPSY INSTRUMENT 18GA X 15CM

    MDR report key: 15959783 · Received December 12, 2022

    Report

    Report Number
    0001625425-2022-01159
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Date of Event
    November 14, 2022
    Report Date
    January 10, 2023
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    KNW
    UDI-DI
    00886333005888
    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

    A REVIEW OF THE BATCH RECORDS CONFIRMED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION AND NO DEVIATIONS OR ANOMALIES WERE FOUND. NO SAMPLE OR IMAGES WERE AVAILABLE FOR EVALUATION. HOWEVER, DUE TO THIS ISSUE BEING REPORTED NUMEROUS TIMES FOR THIS PART, 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 THE PLASTIC HOUSING AND PLUNGER CAN BE SEPARATED MORE EASILY THAN NORMAL. 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.

    Description of Event or Problem · 0

    THE SHELL OF BIOPSY NEEDLE FALLS OFF.

    Description of Event or Problem · 0

    THE SHELL OF BIOPSY NEEDLE FALLS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2229918 SUPERCORE BIOPSY INSTRUMENT 18GA X 15CM SUPERCORE KNW ARGON MEDICAL DEVICES 701118150 11313841 00886333005888

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O