BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYBITE BIOPSY FORCEPS

    MDR report key: 1133482 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03833
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    A SPYBITE BIOPSY FORCEPS WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAM (ERCP) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER A COUPLE OF PASSES THROUGH THE SPYSCOPE CHANNEL, THE FORCEPS WOULD NO LONGER OPEN AND CLOSE. THE PHYSICIAN WAS ABLE TO GET ONE SAMPLE AND COMPLETED THE CASE USING VISUALIZATION. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPYBITE BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00546270 11193830

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK