BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2152031 · Received July 7, 2011

    Report

    Report Number
    3005099803-2011-02339
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 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

    THE PATIENT ID, AGE, GENDER AND WEIGHT ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18 YEARS. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS DEVICE WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6), 2011 ACCORDING TO THE COMPLAINANT, AFTER TAKING A BIOPSY, EXCESSIVE BLEEDING AND TRAUMA WAS VISIBLE TO THE ESOPHAGUS MUCOSAL WALL. REPORTEDLY, ONE OF THE BIOPSIES LEFT A 10MM DEFECT EXPOSING MUSCULARIS. NO INTERVENTION WAS REQUIRED TO TREAT THE BLEED OR THE DEFECT. THE PROCEDURE WAS COMPLETED WITH THIS RADIAL JAW 4 BIOPSY FORCEPS DEVICE. ADDITIONALLY, THE FORCEPS DEVICE WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. POST PROCEDURE, THE PATIENT WAS RELEASED HOME. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE. HOWEVER, THE PATIENT LATER EXPERIENCED ESOPHAGEAL PAIN AND WAS ADMITTED TO THE HOSPITAL FOR ESOPHAGEAL BLEEDING AND TRAUMA. WHILE ADMITTED, THE PATIENT WAS MONITORED FOR PAIN.

    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 M00513401

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization