BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4

    MDR report key: 811286 · Received February 1, 2007

    Report

    Report Number
    6000150-2007-00012
    Event Type
    Injury
    Date Received
    February 1, 2007
    Report Date
    January 22, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    k895415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY WAS UNABLE TO SUPPLY THE LOT NUMBER OF THE DEVICE USED, CONSEQUENTLY, THE MANUFACTURE DATE OF THE DEVICE IS UNKNOWN. THE CUSTOMER INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE COMPLAINT REPORTED TO BOSTON SCIENTIFIC (BSC) ON JANUARY 22, 2007, THAT A PATIENT (AGE & GENDER UNKNOWN) UNDERWENT A DIAGNOSTIC COLONOSCOPY PROCEDURE. THE RADIAL JAW 4 BIOPSY FORCEPS WAS UTILIZED WITHIN THE 'LOWER GI TRACT.' DURING THE PROCEDURE, THE FORCEPS "TORE THE PATIENTS TISSUE RATHER THAN TAKING A CLEAN BITE." THE PATIENT EXHIBITED "EXCESSIVE BLEEDING" AND CLIPS WERE USED TO STOP THE BLEEDING. NO PATIENT SERIOUS INJURY WERE REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 FCL FCL BOSTON SCIENTIFIC CORPORATION M00513372 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention