BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYGLASS DIRECT VISUALIZATION SYSTEM

    MDR report key: 3874584 · Received June 16, 2014

    Report

    Report Number
    3005099803-2014-02236
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    ODF
    PMA / PMN Number
    K090170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS & DELIVERY CATHETER WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE PACKAGING WAS NOTICED TO BE PARTIALLY OPENED. ADDITIONALLY, IT WAS THE INTERNAL PACKAGING SEAL THAT WAS FOUND TO BE INTACT BUT LOOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352484 SPYGLASS DIRECT VISUALIZATION SYSTEM MINI ENDOSCOPE, GASTROENTEROLOGY-UROLOGY ODF BOSTON SCIENTIFIC - MARLBOROUGH M00546230 ML00001804

    Patients

    Seq Age Sex Outcome Treatment
    1