BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYGLASS DIRECT VISUALIZATION PROBE

    MDR report key: 1002546 · Received February 26, 2008

    Report

    Report Number
    3005099803-2008-00214
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    November 28, 2007
    Report Date
    February 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K052194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK; THEREFORE, THE MFR DATE IS UNK. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A DEVICE ANALYSIS CANNOT NOT BE PERFORMED; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT IS UNDETERMINED. THE DECEMBER 2007 15-MONTH SPYGLASS DIRECT VISUALIZATION PROBE PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE THIRD OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT #3005099803-2008-00216 FOR THE EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPYGLASS DIRECT VISUALIZATION PROBE KOG BOSTON SCIENTIFIC CORPORATION M00546030 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R