BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPINCE SOFT TISSUE BIOPSY INSTRUMENT

    MDR report key: 2906799 · Received January 8, 2013

    Report

    Report Number
    1036710-2013-00002
    Event Type
    Other
    Date Received
    January 8, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 19, 2012
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    KNW
    PMA / PMN Number
    K904987A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOGRAPHIC IMAGES WERE SUPPLIED OF THE PRODUCT USED IN THE PROCEDURE. THE TIP OF THE BIOPINCE NEEDLE SET IS CRUSHED INWARD. OUR DFU STATES THAT THE BIOPINCE INSTRUMENT IS FOR USE ONLY FOR CORE BIOPSIES OF SOFT TISSUE, SUCH AS LIVER, KIDNEY, ABDOMINAL MASSES, ETC., AS THEY USED THE LICENSED PHYSICIAN. THE CUSTOMER STATES THEY USED THE DEVICE FOR A MUSCLE BIOPSY. DAMAGE MAY BE EXPERIENCED WITH THE BIOPINCE DEVICE IF THE DEVICE IS USED TO OBTAIN BIOPSY FROM SOMETHING OTHER THAN SOFT TISSUES. WE WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    DURING A MUSCLE BIOPSY PROCEDURE, CUSTOMER STATED THAT THE DEVICE TIP FRACTURED UPON DEPLOYMENT. REMOVAL OF THE DEVICE CAUSED INCREASED PAIN TO THE PT AND A PIECE OF THE DEVICE TIP WERE LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10227 BIOPINCE SOFT TISSUE BIOPSY INSTRUMENT SOFT TISSUE BIOPSY INSTRUMENT KNW MEDICAL DEVICE TECHNOLOGIES, INC. 370-1080-01 120127QI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other