BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAMMOTOME 8G STEREOTACTIC PROBE

    MDR report key: 2222535 · Received August 16, 2011

    Report

    Report Number
    3008492462-2011-00006
    Event Type
    Other
    Date Received
    August 16, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 16, 2011
    Manufacturer
    DEVICOR MEDICAL PRODUCTS INC.
    Product Code
    KNW
    PMA / PMN Number
    K003297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED AND NOT AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    A DOCTOR PERFORMING A STEREOTACTIC PROCEDURE PLACED HIS INDEX FINGER ON THE EXPOSED APERTURE OPENING FROM THE PATIENT'S BREAST. THE CUTTER WAS ACTIVATED AND THE DOCTOR'S FINGER WAS CUT. THERE WERE NO PATIENT CONSEQUENCES. FOLLOW-UP WITH THE SUPERVISOR OF THE FACILITY, MS THEMA REEVES, INDICATED THE DOCTOR WAS TRYING TO GET MORE VACUUM AND PLACED HIS FINGER NEAR THE PROBE AND ACTIVATED IT THINKING HE HAD ACTIVATED THE VACUUM NOT THE CUTTER. THE DOCTOR REMOVED HIS GLOVE, DISINFECTED HIS FINGER, PLACED A BANDAGE ON THE CUT AND RE-GLOVED TO COMPLETE THE PROCEDURE. DOCTOR REFUSED ADDITIONAL MEDICAL CARE. THE DOCTOR IS DOING FINE. AN INCIDENT REPORT WAS FILED AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME 8G STEREOTACTIC PROBE NONE KNW DEVICOR MEDICAL PRODUCTS INC. MST8 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR