BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOMARK BIOPSY IDENTIFIER

    MDR report key: 3922457 · Received June 3, 2014

    Report

    Report Number
    3008492462-2014-00019
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 3, 2014
    Manufacturer
    DEVICOR MEDICAL PRODUCTS INC.
    Product Code
    NEU
    PMA / PMN Number
    K082278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 EXTREMELY SHARP EDGES ALONG THE APERTURE OPENING TO EFFECTIVELY EXCISE TISSUE. REMOVING THE APPLICATOR SHAFT CREATES THE PASSIBILITY 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: WARNING: FAILURE TO ALIGN THE MAMMOMARK APPLICATOR AS SPECIFIED MAY RESULT IN IMPROPER DEPLOYMENT OF THE COLLAGEN PLUG AND POSSIBLE TIP SHEAR. WARNING #10: REMOVE THE MAMMOMARK APPLICATOR AND THE MAMMOTOME BIOPSY PROBE TOGETHER AS A SINGLE UNIT FROM THE SITE AND OBTAIN IMAGES TO CONFIRM MARKER PLACEMENT.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT ACCOUNT HAD ISSUE DEPLOYING TWO MARKERS DURING REVOLVE CASE. STATED FIRST ONE DID NOT DEPLOY AT ALL AND SECOND ONE WAS SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323180 MAMMOMARK BIOPSY IDENTIFIER TISSUE MARKER NEU DEVICOR MEDICAL PRODUCTS INC. MMK0802 F1138516D1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK