BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1191095 · Received September 26, 2008

    Report

    Report Number
    3005099803-2008-04893
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT THE FORCEP WOULD NOT CLOSE PROPERLY. IT APPEARED THAT THERE WAS NO STRENGTH IN THE CUPS ONCE THE HANDLE WAS CLOSED. CASE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. PT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00515992 0011658831

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK