BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICAL MEASUREMENTS INC. RECTAL SUCTION BIOPSY TOOL

    MDR report key: 111557 · Received August 7, 1997

    Report

    Report Number
    MW1011850
    Event Type
    Injury
    Date Received
    August 7, 1997
    Date of Event
    April 6, 1997
    Report Date
    July 1, 1997
    Manufacturer
    MEDICAL MEASUREMENTS INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECTAL MUCOSA TEAR WHILE TAKING BIOPSY WITH SUCTION RECTAL BIOPSY FORCEP. RESULTED IN 300 CC. BLOOD LOSS REQUIRING MASSIVE TRANSFUSION AND OVERSEW OF AN ARTERIAL BLEEDER. PER INDEPENDENT ENGINEERING ASSESSMENT, THE CUTTING EDGE OF THE INTERNAL CUTTER IS QUITE DULL AND SOME MATERIAL LOSS IS EXHIBITED AROUND THE EDGE OF THE BLADE. COMPARISON WITH ANOTHER UNUSED CUTTER WOULD BE USEFUL. TO INVESTIGATE FURTHER, ENGINEER WOULD NEED TO TALK TO THE DEVICE OPERATOR, OTHER STAFF WITH KNOWLEDGE ABOUT THE USE OF THE DEVICE, AND REVIEW ANY INCIDENT REPORTS MADE FOLLOWING THIS PARTICULAR (OR OTHER SIMILAR) INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL MEASUREMENTS INC. RECTAL SUCTION BIOPSY TOOL RECTAL BIOPSY TOOL KNW MEDICAL MEASUREMENTS INC. SBT-100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Hospitalization| R