BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1891400 · Received November 4, 2010

    Report

    Report Number
    3005099803-2010-04709
    Event Type
    Injury
    Date Received
    November 4, 2010
    Report Date
    October 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4) - INTERVENTION REQUIRED TO STOP BLEED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND 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 3 SINGLE-USE BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, HEMATOMA AND BLEEDING OCCURRED AFTER BIOPSY SAMPLES FROM THE CAECUM WERE TAKEN. ADRENALIN WAS ADMINISTERED TO CONTROL THE BLEEDING. THE PHYSICIAN ALLEGES NO DEFICIENCY WITH THE FORCEPS DEVICES. THE PROCEDURE WAS COMPLETED WITH THIS RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515371 0013260990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention