BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1220112 · Received October 31, 2008

    Report

    Report Number
    3005099803-2008-05759
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES CAN NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RADIAL JAW 3 BIOPSY FORCEPS BEING USED DURING A COLONOSCOPY WOULD NOT CLOSE. THE FORCEPS OPENED AND CLOSED ONCE, BUT THE NEXT TIME THE FORCEPS WERE OPENED IT WOULD NOT CLOSE. NO TISSUE SAMPLES WERE TAKEN. THE FORCEPS WERE REMOVED WITH THE JAWS OPENED. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE 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 M00513332 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK