BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYGLASS DIRECT VISUALIZATION PROBE

    MDR report key: 1062383 · Received June 18, 2008

    Report

    Report Number
    3005099803-2008-00743
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K052194
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS CANNOT BE PERFORMED AND THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE APRIL 2008 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A SPYGLASS DIRECT VISUALIZATION PROBE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND A CHOLANGIOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, "... THE PROBE WAS BEING PUT DOWN BY THE SPY SCOPE AND ABOUT HALFWAY DOWN THE PROBE LOST VISUALIZATION COMPLETELY, WENT BLACK." NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT AND THE PT'S CONDITION WAS REPORTED AS "FINE" FOLLOWING THE PROCEDURE.

    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 UNK