BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8G MAMMOMARK BREAST MARKER

    MDR report key: 1190747 · Received October 7, 2008

    Report

    Report Number
    3005075853-2008-02159
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    May 1, 2008
    Report Date
    August 19, 2008
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLEAR TIP SHEARED AT DISTAL TIP. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE INTRODUCER TUBE WAS RECEIVED SHEARED OFF AT THE DISTAL END. A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE DAMAGE FOUND. THE INSTRUMENT COULD NOT BE EVALUATED FOR DEPLOYMENT AS IT WAS RETURNED WITH THE COLLAGEN PLUG ALREADY DEPLOYED. THE PLUNGER ASSEMBLY WORKS AS INTENDED. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, CLIPS WOULD NOT RELEASE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8G MAMMOMARK BREAST MARKER FZP ETHICON ENDO-SURGERY, LLC NA C4G17Z

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE| HOLSTER