BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3

    MDR report key: 1062309 · Received June 18, 2008

    Report

    Report Number
    3005099803-2008-00742
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    K895415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS IS NOT AVAILABLE, THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THE EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    DURING THE COLONOSCOPY PROCEDURE, THE FORCEP WIRE OF RADIAL JAW 3 WAS LOOSE AND DAMAGED THE SCOPE. NO HARM TO THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 EOQ BOSTON SCIENTIFIC CORPORATION M00515993 0011525175

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR