BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 15284575 · Received August 24, 2022

    Report

    Report Number
    3005580113-2022-00095
    Event Type
    Injury
    Date Received
    August 24, 2022
    Date of Event
    January 25, 2013
    Report Date
    August 24, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: FGE CATHETER, BILIARY, DIAGNOSTIC.

    Description of Event or Problem · 0

    WILCOX ET AL 2013 ¿ ¿BILIARY SPHINCTEROTOMY IS NOT REQUIRED FOR BILE DUCT STENT PLACEMENT¿. DURING THIS STUDY PERIOD, OUR PRACTICE HAS BEEN TO ROUTINELY PLACE A SINGLE 7 OR 10 FR PLASTIC (COOK INC., WINSTON SALEM, NC, USA) OR METAL STENT. DURING THIS TIME, THREE EXPERIENCED THERAPEUTIC ENDOSCOPISTS PLACED THESE STENTS. IN GENERAL, SEMS WERE PLACED IN PATIENTS WITH LOCALLY ADVANCED MALIGNANT DISEASE WITH GOOD FUNCTIONAL STATUS. WE PREFER PLACEMENT OF 10-FR BILIARY PLASTIC STENTS IN ALL PATIENTS EXCEPT CHILDREN AND THOSE WITH SMALL BILE LEAKS. SPHINCTEROTOMY WAS DONE USING AN ERBE GENERATOR (ERBE USA, MOULTON, GA, USA) USING THE ENDOCUT FEATURE. ALL COMPLICATIONS WERE ASSESSED PROSPECTIVELY WITH FOLLOW UP AT 24¿48 H AND 1 MONTH BY AN EXPERIENCED NURSE TO CHECK FOR COMPLICATIONS THAT WERE RECORDED USING CONSENSUS CRITERIA. PANCREATITIS (25): OF THE PATIENTS WITH PANCREATITIS, IT WAS FOUND TO BE MILD IN 17 AND MODERATE IN EIGHT PATIENTS. CHOLANGITIS (3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323866 UNKNOWN FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention