BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE BILIARY STENT V

    MDR report key: 3001323 · Received March 5, 2013

    Report

    Report Number
    8010047-2013-00041
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    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

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOLLOWED UP WITH THE USER FACILITY TO OBTAIN MORE DETAILED INFORMATION. THE USER FACILITY REPORTED THAT THE PERFORATION WAS FOUND TWO DAYS LATER OF THE IMPLANTATION AND THE FACILITY CONCLUDED THAT THE EVENT WAS ONE ON THE INEVITABLE COMPLICATION IN THE PROCEDURE. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OMSC FOR EVALUATION, BECAUSE THE FACILITY DISCARDED THE DEVICE. HOWEVER, THERE WERE NO ABNORMALITIES RELATED TO THE EVENT IN THE SUBJECT DEVICE MANUFACTURING RECORDS. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE PHYSICIAN FOUND THE MIGRATION OF THE SUBJECT DEVICE AND THE PERFORATION OF THE DUODENUM WALL BY THE DISTAL END OF THE SUBJECT DEVICE. THE PATIENT WAS SAID TO HAVE BEEN TRANSPORTED FOR OPEN SURGERY TO TREAT THE PERFORATION. THE PATIENT WAS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93287 SINGLE USE BILIARY STENT V BILIARY STENT FGE OLYMPUS MEDICAL SYSTEMS CORPORATION PBD-V600R-0707 29K OR 28K OR 24K

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention