BEUDAMED
    FDA Adverse Event Other Summary report: N

    SINGLE USE BILIARY STENT V

    MDR report key: 2503919 · Received March 21, 2012

    Report

    Report Number
    8010047-2012-00071
    Event Type
    Other
    Date Received
    March 21, 2012
    Date of Event
    February 23, 2012
    Report Date
    February 23, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE WAS DISCARDED BY THE USER FACILITY AND NOT RETURNED TO OMSC, OLYMPUS MEDICAL SYSTEMS CORP (OMSC) COULD NOT EVALUATE THE DEVICE. THEREFORE, THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OMSC HAS CHECKED THE MANUFACTURE HISTORY OF THE SUBJECT DEVICE, THERE WAS NO IRREGULARITY FOUND. IN ADDITION, THE USER FACILITY REPORTED THAT THERE WAS NO IRREGULARITY FOUND IN THE INSPECTION PRIOR TO USE. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A CT SCAN FOR THE PT, WHO UNDERWENT A BILIARY STENT INDWELLING PROCEDURE, THE PHYSICIAN FOUND THE DISTAL END OF THE STENT WAS BURIED INTO THE DUODENUM WALL. CONSIDERING THE POSSIBILITY OF PERFORATION, THE USER FACILITY PERFORMED AN ENDOSCOPIC EXAMINATION. AS THE RESULT OF THE ENDOSCOPY, ALTHOUGH A SLIGHT BLEEDING FROM THE DUODENUM WALL WAS REPORTEDLY OBSERVED, THERE WAS NO PERFORATION. THE PHYSICIAN TREATED THE BLEEDING AREA WITH A UNSPECIFIED CLIP. THE PT RECOVERED AND WAS REPORTEDLY DISCHARGED FROM THE HOSP LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE USE BILIARY STENT V BILIARY STENT FGE OLYMPUS MEDICAL SYSTEMS CORPORATION PBD-200-1005 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention