BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW? 4

    MDR report key: 3140522 · Received May 31, 2013

    Report

    Report Number
    3005099803-2013-04715
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 LC BIOPSY FORCEPS WAS USED DURING A EGD WITH BARRETTS SURVEILLANCE BIOPSY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS DIFFICULT TO RETRIEVE THE BIOPSY. ADDITIONAL FORCE WAS REQUIRED TO REMOVE THE TISSUE SAMPLE. IT WAS ALSO NOTED THAT ADDITIONAL FORCE WAS REQUIRED TO REMOVE THE FORCEPS FROM THE SCOPE. POST PROCEDURE, APPROXIMATELY A FEW HOURS LATER, THE PATIENT PRESENTED WITH HEMATEMESIS FROM AN UPPER GI BLEED. THE PATIENT WAS HOSPITALIZED AND ON (B)(6) 2013 A REPEAT EGD PROCEDURE WAS PERFORMED. AN ACTIVE BLEED WAS IDENTIFIED IN THE DISTAL ESOPHAGUS AT THE BIOPSY SITE. EPINEPHRINE INJECTIONS WERE ADMINISTERED AND THE BLEED WAS CAUTERIZED, SUCCESSFULLY STOPPING THE BLEED. THE PATIENT WAS DISCHARGED ON (B)(6) 2013 AND WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240801 RADIAL JAW? 4 FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00513332

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R