BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2191354 · Received August 4, 2011

    Report

    Report Number
    3005099803-2011-02662
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE/DATE OF BIRTH AND WEIGHT ARE UNKNOWN. HOWEVER, PATIENT OVER 18 YEARS OLD. CONCOMITANT MEDICAL PRODUCT - OLYMPUS SCOPE. 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 HAS BEEN 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS DEVICE WAS USED DURING AN EARLY AFTERNOON COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, MULTIPLE BIOPSIES WERE TAKEN FROM THE COLON. THE BIOPSIES OBTAINED WERE REPORTED TO BE LARGE AND ONE BIOPSY REQUIRED AN IMMEDIATE APPLICATION OF A RESOLUTION CLIP. THE PROCEDURE WAS COMPLETED WITH THIS RADIAL JAW 4 BIOPSY FORCEPS DEVICE. REPORTEDLY, THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED LATER THAT AFTERNOON, THE PATIENT PRESENTED WITH BLEEDING IN THE RECOVERY AREA. A FOLLOW-UP COLONOSCOPY WAS PERFORMED AND FOUND BLEEDING AT THE BIOPSY SITES. FOURTEEN RESOLUTIONS CLIPS WERE USED TO STOP THE BLEEDING. THE PATIENT'S CONDITION POST PROCEDURE WAS REPORTED AS BEING FINE.

    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 M00513332

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention