BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18GX10CM

    MDR report key: 10359957 · Received August 3, 2020

    Report

    Report Number
    1625425-2020-00452
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    June 1, 2020
    Report Date
    August 3, 2020
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    KNW
    UDI-DI
    00886333004379
    PMA / PMN Number
    K904987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    FOLLOW UP.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    APPLICATION/PROCEDURE: TAKING A BIOPSY. PROCESS/PRODUCT GROUP: BIOPSY NEEDLE. COMPLAINT: THE TIP OF THE NEEDLE HAS A DAMAGE. 1 OF THE 3 END POINTS SEEMS DIFFERENT. THIS HAS ALREADY BEEN OBSERVED WHEN PASSING THROUGH THE SKIN. BEFORE THE BIOPTEER ENTERED THE PATIENT¿S SKIN, THE DEVICE WAS NOT DROPPED. THE DEVICE IS FIRED AT MOST 1X TO ILLUSTRATE THE SOUND OF THE DEVICE TO THE PATIENT. THE NEEDLE FELT A BIT FRAYED WHEN INSERTED INTO THE PATIENT, IT LOOKED LIKE THERE WAS SOME KIND OF BARB ON THE TIP. THE NEEDLE WAS THEN REMOVED WITHOUT BIOPSYING INTO THE PATIENT AND THE TIP WAS INSPECTED. IT INDEED FELT UNEVEN, BUT IT WAS NOT VISIBLE WHAT EXACTLY WAS GOING ON. PRESUMABLY 1 OF THE TEETH OF THE OUTER NEEDLE WAS STANDING SLIGHTLY OUTWARD. PUNCTURED THROUGH THE PATIENTS SKIN, BUT NO BIOPSY TAKEN, DEVICE IS CONTAMINATED. THIS COMPLAINT IS INTERNALLY REGISTRATED UNDER NO. FMH.20-31 BY THE FMH MEDICAL QUALITY DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818645 BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18GX10CM KNW ARGON MEDICAL DEVICES 360-1080-01 11279219 00886333004379

    Patients

    Seq Age Sex Outcome Treatment
    1 Other