BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8G MAMMOMARK BREAST MARKER

    MDR report key: 1781503 · Received August 3, 2010

    Report

    Report Number
    3005075853-2010-04422
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K003777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CLEAR TIP SHEARED AT DISTAL TIP. THE (B)(4) DEVICE A WAS RECEIVED WITH THE INTRODUCER TUBE SHEARED OFF AT THE DISTAL TIP AND THE COLLAGEN PLUG WAS MISSING. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE ESTABLISHED AS TO HOW THE DAMAGE OCCURRED. HOWEVER, A POTENTIAL CAUSE IS THE REMOVAL OF THE MAMMOMARKER FROM THE DISPOSABLE PROBE WHILE IT'S STILL INSERTED INTO THE PATIENT BREAST. ONCE THE COLLAGEN PLUG HAS BEEN DEPLOYED, THE PROBE AND MAMMOMARKER HAVE TO BE REMOVED TOGETHER (AT THE SAME TIME) FROM THE PATIENT BREAST TO AVOID DAMAGE TO THE MAMMOMARKER INTRODUCER TUBE SUCH AS THE ONE RECEIVED FOR ANALYSIS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE (B)(4) APPLIERS B AND C WERE RECEIVED IN GOOD PHYSICAL CONDITION AND ALREADY DEPLOYED (WITHOUT THE COLLAGEN PLUG). THE FIRING MECHANISMS WAS TESTED AND THEY WERE FULLY FUNCTIONAL. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. DEVICE B AND C ADDITIONAL INFORMATION: BATCH # F9HL6N. EXPIRATION DATE: 09/2014. MANUFACTURING DATE: 10/2009.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    IT WAS REPORTED THE FIRST MARKER WAS DEPLOYED BUT THE COLLAGEN PLUG CAME OUT WITH THE APPLICATOR. A SECOND MARKER WAS TRIED, DEPLOYED AND THE COLLAGEN ALSO CAME OUT WITH THE APPLICATOR. A THIRD MARKER WAS TRIED BUT THE TIP OF THE MARKER WAS SHEARED OFF INTO THE BREAST. THE CUSTOMER WAS ABLE TO RETRIEVE THE SHEARED OFF PIECE OF THE APPLICATOR. A FOURTH MARKER WAS TRIED, DEPLOYED SUCCESSFULLY, AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. PATIENT INFORMATION WAS REQUESTED BUT LITTLE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8G MAMMOMARK BREAST MARKER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE, HOLSTER