BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1181373 · Received September 23, 2008

    Report

    Report Number
    3005099803-2008-04772
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING A COLONOSCOPY THE PHYSICIAN WAS UNABLE TO USE THE RADIAL JAW 4 BIOPSY FORCEPS TO TAKE A BIOPSY. THE FORCEPS WERE PUT THROUGH THE SCOPE, THE FORCEPS OPENED BUT WOULD NOT CLOSE; PHYSICIAN WAS UNABLE TO TAKE THE BIOPSY. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE CASE. THE PT IS REPORTED TO BE "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00513361 0011470742

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK