BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOMARK BIOPSY IDENTIFIER

    MDR report key: 3912086 · Received May 22, 2014

    Report

    Report Number
    3008492462-2014-00017
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 22, 2014
    Manufacturer
    DEVICOR MEDICAL PRODUCTS INC.
    Product Code
    NEU
    PMA / PMN Number
    K082278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS, WHICH PREVENTED A FULL INVESTIGATION AND ANALYSIS OF THE ROOT CAUSE. HOWEVER, BASED ON OUR KNOWLEDGE OF THE DEVICE DESIGN AND ITS PRESCRIBED USE, THE MOST LIKELY SCENARIO IS THAT THE USER REMOVED THE MARKER APPLICATOR SEPARATELY FROM THE BIOPSY PROBE. TIP SHEAR HAS BEEN IDENTIFIED AS A POTENTIAL RISK WHENEVER THE APPLICATOR SHAFT IS REMOVED THROUGH THE BIOPSY PROBE. OUR MAMMOTOME VACUUM ASSISTED BIOPSY PROBES CONTAIN EFFECTIVELY EXCISE TISSUE. REMOVING THE APPLICATOR SHAFT CREATES THE POSSIBILITY OF THE APPLICATOR CATCHING ON ONE OF THESE EDGES AND SHEARING. AS A MITIGATION STEP TO ADDRESS THIS RISK, WE PROVIDE CONTRAINDICATION LANGUAGE AND INSTRUCTION WITHIN THE INSTRUCTIONS FOR USE. THROUGH FOLLOW-UP WITH THE SALES REP, BIOPSY RESULTS WERE BENIGN.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT THE TIP OF MARKER SHEARED OFF IN PATIENT'S BREAST POST US GUIDED BIOPSY. DOCTOR TRIED TO REMOVE MARKER PRIOR TO REMOVING PROBE. DOCTOR IS GOING TO RECOMMEND SURGICAL REMOVAL. DEVICE IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304401 MAMMOMARK BIOPSY IDENTIFIER TISSUE MARKER NEU DEVICOR MEDICAL PRODUCTS INC. MAM3008 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK