BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 JUMBO

    MDR report key: 787447 · Received November 28, 2006

    Report

    Report Number
    6000150-2006-00019
    Event Type
    Injury
    Date Received
    November 28, 2006
    Date of Event
    October 31, 2006
    Report Date
    November 2, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    k895415
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H4- USER FACILITY WAS UNABLE TO SUPPLY THE CORRECT LOT NUMBER OF THE DEVICE USED; CONSEQUENTLY, THE MANUFACTURE DATE OF THE DEVICE IS UNKNOWN. THE COMPLAINANT 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 AT THIS TIME.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED IN 2006, MALE PATIENT CAME TO THE HOSPITAL WITH A GI BLEED. THE PHYSICIAN PERFORMED A COLONOSCOPY, TAKING NUMEROUS BITES THROUGHOUT THE 5 SECTIONS OF THE COLON, USING THE RADIAL JAW 4 BIOPSY FORCEPS. ONE DAY LATER, THE PATIENT RETURNED TO THE HOSPITAL SEPTIC WITH A WHITE BLOOD CELL COUNT OF 23000 (TREATMENT OF THE SEPSIS IS UNKNOWN). THE PATIENT'S STATUS AND CONDITION IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention