BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1071007 · Received July 3, 2008

    Report

    Report Number
    8010047-2008-00113
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Report Date
    June 5, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR INVESTIGATION. THE USERS REPORTED THAT THE CLIP AND DELIVERY SYSTEM WAS IMMEDIATELY DISCARDED FOLLOWING ITS USE. THE CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. OLYMPUS IS ATTEMPTING TO GATHER ADDITIONAL INFORMATION REGARDING THIS REPORTED EVENT, AND WILL SUPPLEMENT THIS REPORT WITHIN THIRTY DAYS. THIS REPORT IS FOR ONE OF THREE SIMILAR REPORTS FOR THIS FACILITY. PLEASE REFER TO MANUFACTURER REPORT NUMBER: 8010047-2008-00112 AND 8010047-2008-00114 FOR OTHER RELATED REPORTS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY PROCEDURE, THE CLIP FIRED PREMATURELY, AND DID NOT DETACH AS EXPECTED. AS THE USER ATTEMPTED TO PULL THE CLIP BACK THROUGH THE INSTRUMENT CHANNEL OF THE ENDOSCOPE, THE CLIP BECAME LODGED IN THE CHANNEL, AND SUBSEQUENTLY FELL INTO THE PATIENT'S STOMACH. THE USER FACILITY HAS PROVIDED CONFLICTING INFORMATION REGARDING WHAT, IF ANY ADDITIONAL INTERVENTION MAY HAVE BEEN REQUIRED TO ADDRESS THIS PHENOMENON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ROTATABLE SINGLE USE CLIP FIXING DEVICE MND OLYMPUS MEDICAL SYSTEMS CORPORATION HX-201UR-13 79K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention