BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS

    MDR report key: 1456375 · Received June 18, 2009

    Report

    Report Number
    3005099803-2009-02917
    Event Type
    Malfunction
    Date Received
    June 18, 2009
    Date of Event
    May 21, 2009
    Report Date
    May 21, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KGE
    PMA / PMN Number
    K910964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP, THAT SMALL BROWN SHAVINGS WERE NOTED INSIDE THE STERILE PACKAGE. THERE WAS NO PT OR PROCEDURE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 HOT SINGLE-USE BIOPSY FORCEPS KGE BOSTON SCIENTIFIC CORPORATION M00515503 0012362538

    Patients

    Seq Age Sex Outcome Treatment
    1