BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR BIOPSY DRIVER

    MDR report key: 2031712 · Received February 25, 2011

    Report

    Report Number
    2032230-2011-00003
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    SENORX
    Product Code
    KNW
    PMA / PMN Number
    K040842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SERIAL NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY AND SERVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE PHYSICIAN WENT INTO THE BREAST AND WHILE TAKING THE FIRST SAMPLE IN THE 12 O'CLOCK POSITION, THE PHYSICIAN FELT AN ELECTRICAL SHOCK IN THE HAND LEADING UP TO THE ELBOW. THE CUSTOMER REPORTED THAT AT THAT TIME, THE MONITOR APPEARED TO SHOW SOME KIND OF ELECTRICAL INTERFERENCE. THE PHYSICIAN TOOK ANOTHER SAMPLE IN THE 6 O'CLOCK POSITION AND CONCLUDED THE BIOPSY WITH THE SAMPLES COLLECTED. THE PHYSICIAN FELT THE SAMPLES WERE SUFFICIENT. THE PHYSICIAN WAS SEEN BY ANOTHER PHYSICIAN ONSITE AND WENT HOME. IT IS UNK AT THIS TIME WHAT THE PHYSICIAN WAS SEEN FOR. REPORTEDLY, THE PT DID NOT EXPERIENCE ANY ELECTRICAL SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCOR BIOPSY DRIVER KNW SENORX

    Patients

    Seq Age Sex Outcome Treatment
    1