BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW¿ 4

    MDR report key: 2213094 · Received August 16, 2011

    Report

    Report Number
    3005099803-2011-02761
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS UNKNOWN; HOWEVER REPORTED TO BE OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS LARGE CAPACITY WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE BIOPSY BITE CAUSED WHAT WAS CONSIDERED EXCESSIVE BLEEDING. A RESOLUTION CLIP WAS PLACED AND HEMOSTASIS WAS ACHIEVED. THE PROCEDURE WAS COMPLETED WITH THIS RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS LARGE CAPACITY DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: REPORTEDLY THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. ADDITIONALLY, AFTER USE THERE WAS NO DEVICE DAMAGE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW¿ 4 FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513321

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention