BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERCORE BIOPSY INSTRUMENT 16GA X 15CM

    MDR report key: 15191113 · Received August 9, 2022

    Report

    Report Number
    0001625425-2022-01056
    Event Type
    Malfunction
    Date Received
    August 9, 2022
    Date of Event
    June 1, 2022
    Report Date
    September 19, 2022
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    KNW
    UDI-DI
    00886333005826
    PMA / PMN Number
    K974814
    Removal / Correction Number
    1625425-09/30/2021-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE IS UNAVAILABLE FOR EVALUATION. WITHOUT SUCH EVIDENT TO REVIEW, THE COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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

    WHEN PERFORMING BREAST TUMOR PUNCTURE BIOPSY, THE BIOPSY NEEDLE RUPTURED AND INJURED THE FINGERS OF MEDICAL STAFF. IMMEDIATELY REPLACE THE BIOPSY NEEDLE, AND THE MEDICAL STAFF CLEANED AND DISINFECTED THE WOUND.

    Description of Event or Problem · 0

    WHEN PERFORMING BREAST TUMOR PUNCTURE BIOPSY, THE BIOPSY NEEDLE RUPTURED AND INJURED THE FINGERS OF MEDICAL STAFF. IMMEDIATELY REPLACE THE BIOPSY NEEDLE, AND THE MEDICAL STAFF CLEANED AND DISINFECTED THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253978 SUPERCORE BIOPSY INSTRUMENT 16GA X 15CM SUPERCORE KNW ARGON MEDICAL DEVICES 701116150 11321843 00886333005826

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other