BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYGLASS DIRECT VISUALIZATION SYSTEM

    MDR report key: 2485072 · Received March 9, 2012

    Report

    Report Number
    3005099803-2012-00967
    Event Type
    Injury
    Date Received
    March 9, 2012
    Report Date
    February 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    ODF
    PMA / PMN Number
    K090170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICE: OLYMPUS SCOPE. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. THE COMPLAINANT INDICATED THAT THE DEVICE 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS & DELIVERY CATHETER WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SPYSCOPE WAS USED TO COMPLETE THE PROCEDURE. HOWEVER, FOLLOWING THE ERCP, "A TUBULAR PIECE OF PLASTIC OR RUBBER," APPROXIMATELY 2MM X 7MM IN SIZE AND "WHITE/YELLOW" IN APPEARANCE, WAS RECOVERED FROM THE PATIENT'S COMMON BILE DUCT. THE PHYSICIAN SUSPECTS THAT THE FRAGMENT MAY HAVE ORIGINATED FROM THE SPYSCOPE; HOWEVER, SUBSEQUENT EXAMINATION OF THE DEVICE IDENTIFIED NO DAMAGE. REPORTEDLY, NO MALFUNCTION OF THE SPYSCOPE OCCURRED. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention