BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW? 4

    MDR report key: 3913239 · Received July 3, 2014

    Report

    Report Number
    3005099803-2014-02438
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: THE EXACT EVENT DATE IS UNKNOWN, HOWEVER IT WAS REPORTED THAT THE PROCEDURE WAS APPROXIMATELY 7 OR 8 WEEKS PRIOR TO THE AWARE DATE OF (B)(6), 2014. (B)(6). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND 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 STANDARD CAPACITY WITH NEDDLE BIOPSY FORCEPS WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN THE DUODENUM. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE ¿SEEMED TO BE TEARING¿ WHEN TAKING A DUODENAL BIOPSY AND PATIENT HAS EXPERIENCED DELAYED BLEEDING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389783 RADIAL JAW? 4 FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00513412 16869150

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization