BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8G MAMMOMARK BREAST MARKER

    MDR report key: 1080022 · Received July 17, 2008

    Report

    Report Number
    3005075853-2008-00568
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 16, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/17/2008. CLEAR TIP SHEARED AT DISTAL TIP. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE INTRODUCER TIP SHEARED OFF AND MISSING. THE APPLIER WAS RECEIVED WITHOUT THE COLLAGEN PLUG, WHICH DENOTES THAT THE MARKER CLIP WAS ALREADY DEPLOYED. A CORRECTIVE ACTION HAS BEEN INITIATED FOR THE TIP SHEARING ISSUES. EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS. WHILE WE WERE UNABLE TO RE-CREATE THE EVENT, WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE PHYSICIAN WAS UNABLE TO DEPLOY THE MARKER. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCESS BY USING ANOTHER MARKER. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8G MAMMOMARK BREAST MARKER FZP ETHICON ENDO-SURGERY, LLC NA E4LEL8H

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE| HOLSTER