BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1150515 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04407
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING THE ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, HALF THE FORCEPS FELL OFF IN THE PATIENT'S STOMACH. THE BROKEN PIECE WAS SUCTIONED THROUGH THE SCOPE AND WAS RETRIEVED. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. PATIENT IS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00515502 0011720617

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention