BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE CHOLODOCHOSCOPE

    MDR report key: 3893477 · Received June 2, 2014

    Report

    Report Number
    3893477
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    March 28, 2013
    Report Date
    June 2, 2014
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    FBN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD LAPAROSCOPIC CHOLECYSTECTOMY WITH CHOLANGIOGRAMS AND LAPAROSCOPIC COMMON BILE DUCT EXPLORATION WITH MULTIPLE LARGE STONE EXTRACTIONS. FLEXIBLE CHOLEDOCHOSCOPE IN OPERATING ROOM STOPPED WORKING. ON REVIEW THE DEVICE WAS SHOWN TO BE AT THE END OF WORKING LIFE. NO FUTHER INFORMATION IS AVAILABLE.======================MANUFACTURER RESPONSE FOR KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE, FLEXIBLE CHOLODOCHOSCOPE (PER SITE REPORTER).======================NEW SCOPE PURCHASED FROM KARL STORZ UNDER THEIR EXCHANGE PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322672 FLEXIBLE CHOLODOCHOSCOPE CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN KARL STORZ ENDOSCOPY-AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR