BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1392663 · Received May 19, 2009

    Report

    Report Number
    1392663
    Event Type
    Malfunction
    Date Received
    May 19, 2009
    Date of Event
    May 13, 2009
    Report Date
    May 19, 2009
    Manufacturer
    RANFAC CORPORATION
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    DURING A LAP CHOLE, THE TIP OF THE CHOLANGIOGRAM CATHETER BROKE OF INTRAOPERATIVELY AND THE PHYSICIAN RETRIEVED IT FROM THE PATIENT'S ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CATHETER, CHOLANGIOGRAPHY GBZ RANFAC CORPORATION ORC-A-20-4 18363

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR