BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERCORE BIOPSY INSTRUMENT 18GA X 9CM

    MDR report key: 16271747 · Received January 31, 2023

    Report

    Report Number
    0001625425-2023-00949
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    September 1, 2022
    Report Date
    April 25, 2023
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    KNW
    UDI-DI
    00886333005895
    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
    003

    Narratives

    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. AFTER THREE NOTIFICATIONS, THE SAMPLE FROM THE ALLEGED COMPLAINT HAS NOT RETURNED. 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.

    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.

    Description of Event or Problem · 0

    DOCTOR INDICATES THAT THE HANDLE SEPARATES FORM THE NEEDLE ASSEMBLY WITH MINIMAL EFFORT.

    Description of Event or Problem · 0

    DOCTOR INDICATES THAT THE HANDLE SEPARATES FORM THE NEEDLE ASSEMBLY WITH MINIMAL EFFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789524 SUPERCORE BIOPSY INSTRUMENT 18GA X 9CM SUPERCORE KNW ARGON MEDICAL DEVICES 701118090 11248155 00886333005895

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R