BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1242983 · Received November 20, 2008

    Report

    Report Number
    3005099803-2008-06620
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR DEVICE CAUSING TISSUE TEAR. THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURING AND EXPIRATION DATES CAN NOT 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

    IN 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WHEN THE PHYSICIAN CLOSED DOWN ON THE RADIAL JAW 4 BIOPSY FORCEPS, THE TISSUE TORE. THE BIOPSY DID NOT TAKE A CLEAN BITE. A SECOND OF THE SAME DEVICE WAS TRIED AND IT EXPERIENCED THE SAME ISSUE. A THIRD OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT EXPERIENCED AN UPPER GASTROINTESTINAL BLEED DUE TO THE EVENT WHICH PROLONGED THE HOSPITAL STAY. PATIENT IS "STABLE". NOTE: THIS IS THE FIRST REPORT OF TWO RELATED COMPLAINTS. PLEASE REFER TO MFR # 3005099803-2008-06621.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00513374 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization