BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYGLASS DIRECT VISUALIZATION SYSTEM

    MDR report key: 2250133 · Received September 15, 2011

    Report

    Report Number
    3005099803-2011-03172
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K052194
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DIRECT VISUALIZATION PROBE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE FOR STONE THERAPY PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, WHEN THE SPYGLASS PROBE WAS ADVANCED INTO THE SPYSCOPE, THE PROBE BROKE IN TWO WHERE THE CATHETER DIAMETER TRANSITIONS FROM THICK TO THIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPYGLASS DIRECT VISUALIZATION PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPYGLASS DIRECT VISUALIZATION SYSTEM ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00546030 0001025103

    Patients

    Seq Age Sex Outcome Treatment
    1