BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1990092 · Received February 15, 2011

    Report

    Report Number
    3005099803-2011-00330
    Event Type
    Injury
    Date Received
    February 15, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, AGE/DATE OF BIRTH, AND WEIGHT ARE UNKNOWN. HOWEVER, PATIENT OVER 18 YEARS OLD. THE EVENT DATE IS UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4), NO CODE AVAILABLE (INTERVENTION REQUIRED TO STOP BLEED). 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 STOMACH BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS COMPLETED WITH THIS RADIAL JAW 4 BIOPSY FORCEPS DEVICE. HOWEVER, AFTER BEING DISCHARGED, THE PATIENT NOTICED BLOODY STOOL AND RETURNED TO THE HOSPITAL. THE PATIENT PRESENTED WITH ANEMIA SO THE PHYSICIAN PERFORMED AN ENDOSCOPIC EXAMINATION. COAGULATED BLOOD WAS VISIBLE AT THE BIOPSY SITE AND WAS TREATED BY PLACING A CLIP AT THAT LOCATION. THE ACCOUNT REPORTED THAT THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. ADDITIONALLY, NO DEVICE ISSUES WERE IDENTIFIED DURING THE PROCEDURE. THE PATIENT WAS HOSPITALIZED FOUR DAYS, BUT HAS SINCE BEEN RELEASED. THE PATIENT'S CONDITION WAS REPORTED AS BEING GOOD.

    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 M00513381

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R