BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2143310 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02257
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS UNKNOWN; HOWEVER REPORTED TO BE OVER 18 YEARS OLD. 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 4 SINGLE USE BIOPSY FORCEPS JUMBO CAPACITY DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, WHILE TAKING THE FIRST BIOPSY, THE FORCEPS DID NOT CUT CLEANLY, BUT TORE THE TISSUE. A PATIENT BLEED OCCURRED, BUT IT WAS NOT EXCESSIVE. THE PHYSICIAN PLACED 1-2 RESOLUTION CLIPS AT THE BIOPSY SITE. THE PROCEDURE WAS COMPLETED WITH THE SAME RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS JUMBO CAPACITY DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE. POST PROCEDURE, THE PATIENT WAS OBSERVED FOR AN HOUR, THEN DISCHARGED.

    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 M00513372 14290590

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention