BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1140588 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04179
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AFTER TAKING THE BIOPSY WITH THE RADIAL JAW 3 FORCEPS AND OPENING THE FORCEP, WHILE OUTSIDE OF THE PATIENT, ONE OF THE "JAWS" FELL OFF. THE CASE WAS COMPLETED WITH ANOTHER DEVICE WITH NO PATIENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00515501 11629635

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK