BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MST8 - STEREOTACTIC PROBE

    MDR report key: 2132626 · Received June 13, 2011

    Report

    Report Number
    MW5020981
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE ACQUIRED TWO BREAST BIOPSIES BEFORE LOCKING ON AN ATTEMPT TO ACQUIRE A THIRD. DEVICE MANUALLY REMOVED FROM PT. USED LESS THAN 5 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MST8 - STEREOTACTIC PROBE STEREOTACTIC BIOPSY DEVICE KNW ETHICON ENDO-SURGERY H43950

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Disability