BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MST8 FINAL ASSY JRZ

    MDR report key: 1820949 · Received September 27, 2007

    Report

    Report Number
    1527736-2007-06411
    Event Type
    Malfunction
    Date Received
    September 27, 2007
    Date of Event
    September 11, 2007
    Report Date
    September 11, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K003297
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE THE WHITE PLASTIC PIECE BEHIND THE COLLECTION CHAMBER ON THE DEVICE CRACKED AND BROKE. THERE WAS A PIECE OF PLASTIC IN THE SPECIMEN. THERE WAS A POST BIOPSY X-RAY COMPLETED AND NO OTHER PARTICLES WERE SEEN. A DAMAGED PROBE ERROR WAS SEEN. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MST8 FINAL ASSY JRZ KNW ETHICON ENDO SURGERY, INC (CINCINNATI) NA C4FY7R

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE| HOLSTER