BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BIOPSY FORCEPS

    MDR report key: 97035 · Received June 10, 1997

    Report

    Report Number
    MW1011438
    Event Type
    Malfunction
    Date Received
    June 10, 1997
    Date of Event
    May 28, 1997
    Report Date
    June 2, 1997
    Manufacturer
    MEDICAL INNOVATIONS CORP.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A GASTROSCOPE AND OBTAINING A BIOPSY, THE BIOPSY FORCEPS WOULD NOT CLOSE. THE FORCEPS HAD A BROKEN WIRE ON THE JAW. THE BIOPSY COULD NOT BE OBTAINED. THE SCOPE HAD TO BE REMOVED WITH THE FORCEPS OUT OF THE END OF THE SCOPE, OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE BIOPSY FORCEPS DISPOSABLE BIOPSY FORCEPS KNW MEDICAL INNOVATIONS CORP. * 0082N7

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other