BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3

    MDR report key: 1140696 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04161
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT# 3005099803-2008-04162. IT WAS REPORTED THAT DURING AN ESOPHOGASTRODUODUDENOSCOPY (EGD) WITH DILATATION PROCEDURE, DEVICE DAMAGE AND A BALLOON PUNCTURE OCCURRED. UPON OPENING THE CRE 12MM X 15MM BALLOON DILATATION CATHETER AND THE RJ3 LARGE CAPACITY BIOPSY FORCEPS, IT WAS NOTED THAT THE "FORCEPS WAS BENT AT THE END, AND THE BALLOON WAS PUNCTURED". IT WAS FURTHER REPORTED THAT THERE WAS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE PACKAGE. THE DEVICE WAS NOT USED ON THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 EOQ BOSTON SCIENTIFIC M00515993 0011598429

    Patients

    Seq Age Sex Outcome Treatment
    1