BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2326880 · Received November 7, 2011

    Report

    Report Number
    3005099803-2011-03840
    Event Type
    Injury
    Date Received
    November 7, 2011
    Date of Event
    September 7, 2011
    Report Date
    October 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 ENDOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A BIOPSY WAS RETRIEVED FROM THE DIGESTIVE TRACK TO COMPLETE THE CASE. HOWEVER, THE FOLLOWING NIGHT, THE PATIENT PRESENTED WITH HEMATEMESIS AND MELENA, WHICH WAS ATTRIBUTED TO A BLEED WITHIN THE DIGESTIVE TRACK. REPORTEDLY, THE BLEED WAS ENHANCED BY THE PATIENT'S RESUMPTION OF AVK ANTICOAGULANT TREATMENT. THE PATIENT RECEIVED A BLOOD TRANSFUSION AND HEMOSTASIS WAS PERFORMED THROUGH CLIP PLACEMENT. THE PATIENT WAS HOSPITALIZED FOR FIVE ADDITIONAL DAYS, BUT HAS SINCE BEEN RELEASED. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS BEING SATISFACTORY.

    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 UNK698

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R