BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1200087 · Received October 15, 2008

    Report

    Report Number
    3005099803-2008-05257
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY BOSTON SCIENTIFIC THAT DURING PREPARATION, THE RADIAL JAW 3 BIOPSY FORCEPS JAWS WOULD NOT CLOSE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS AND THE PATIENT IS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00515993 9830220

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR