BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME** EX PROBE AND VACUUM SET

    MDR report key: 1792010 · Received August 10, 2010

    Report

    Report Number
    3005075853-2010-04558
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 15, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KNW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE PROBE WOULD NO LONGER CUT AFTER CUTTING A FEW PIECES OF TISSUE. 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 MAMMOTOME** EX PROBE AND VACUUM SET KNW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER, CONTROL MODULE