BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1242986 · Received November 20, 2008

    Report

    Report Number
    3005099803-2008-06605
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER FOR DEVICE CAUSED TISSUE TEAR. THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    ON THE EVENT DATE, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT DURING A PROCEDURE, THERE WAS TEARING OF THE TISSUE DUE TO THE RADIAL JAW 4 BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS. PATIENT IS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00513332 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other