BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1843104 · Received September 23, 2010

    Report

    Report Number
    3005099803-2010-04058
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND 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 COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, 36 BIOPSY SAMPLES WERE TAKEN FROM A PATIENT WITH LONGSTANDING CROHN COLITIS AND EXTENSIVE BOWEL FIBROSIS. THE PHYSICIAN INDICATED THAT UNUSUALLY LARGE SAMPLES HAD BEEN RETRIEVED. HOWEVER, NO DEVICE ISSUES WERE IDENTIFIED PRIOR TO BEGINNING THE PROCEDURE. AT 24 HOURS POST PROCEDURE, THE PATIENT DEVELOPED ABDOMINAL PAIN. SHE WAS ADMITTED TO THE HOSPITAL AND HAD AN ABDOMINAL X-RAY WHICH REVEALED A PERFORATED BOWEL. THE ACCOUNT REPORTED THAT THE PERFORATION WAS TREATED WITH ANTIBIOTICS. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS BEING WELL.

    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 M00513402

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| O