BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11G MAMMOMARK BREAST MARKER

    MDR report key: 1190927 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03527
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K003777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER #= D9DH0R (BATCH # FOR DEVICE B); EXP DATE = 02/2012 (DEVICE B). MFG DATE 03/2007. THE ANALYSIS RESULTS FOUND THAT THE DEVICES A AND B WERE RECEIVED WITH THE INTRODUCER TIP SHEARED OFF AND MISSING. THE APPLIERS WERE 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 MFG PROCESS. 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 MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST BIOPSY, TWO MAMMOMARKERS WOULD NOT DEPLOY INTO BIOPSY SITE. THE PHYSICIAN WAS ABLE TO COMPLETE THE BIOPSY USING A THIRD MARKER. THERE WERE NO PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11G MAMMOMARK BREAST MARKER NONE FZP ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4HY7D

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER| CONTROL MODULE