BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1981922 · Received February 8, 2011

    Report

    Report Number
    3005099803-2011-00264
    Event Type
    Injury
    Date Received
    February 8, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT ID AND WEIGHT ARE UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS WAS USED DURING A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE DUODENUM WAS PERFORATED. THE PROCEDURE WAS COMPLETED WITH THIS RADIAL JAW 4 BIOPSY FORCEPS DEVICE. THE ACCOUNT REPORTED THAT PRIOR TO USE THE DEVICE WAS INSPECTED AND NO ANOMALIES WERE NOTED. IT IS NOT KNOWN IF ANY ADDITIONAL INTERVENTION WAS REQUIRED TO TREAT THE PERFORATION. THE PATIENT WAS HOSPITALIZED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513381

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization