BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYGLASS DIRECT VISUALIZATION PROBE

    MDR report key: 1211096 · Received October 24, 2008

    Report

    Report Number
    3005099803-2008-05491
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K052194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF FIVE DEVICES REPORTED FOR THE EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 24, 2008, THAT A DISTAL BILE DUCT PERFORATION WAS OBSERVED AFTER A PROCEDURE PERFORMED ON THE PREVIOUS MONTH, USING A SPYGLASS DIRECT VISUALIZATION PROBE (PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN). THE PATIENT WAS ADMITTED TO THE HOSPITAL AND LATER RELEASED; THE PATIENT'S CONDITION WAS REPORTED TO BE "FINE". ACCORDING TO THE COMPLAINANT, THE RELATIONSHIP BETWEEN THE DUCT PERFORATION AND THE SPYGLASS DIRECT VISUALIZATION PROBE DEVICE IS UNKNOWN. REFER TO MFR REPORT #3005099803-2008-05487, 3005099803-2008-05490, 3005099803-2008-05492, AND 3005099803-2008-05502 FOR THE OTHER FOUR DEVICES USED IN 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 Hospitalization| O