BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ROTATABLE CLIP FIXING DEVICE

    MDR report key: 4030979 · Received July 16, 2014

    Report

    Report Number
    8010047-2014-00388
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICES HAVE NOT BEEN RETURNED TO OMSC FOR INVESTIGATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE INSTRUCTION MANUAL HAS WARNED USERS THAT "DO NOT TRY TO FORCIBLY WITHDRAW THE INSTRUMENT FROM THE ENDOSCOPE IF THE CLIP CANNOT BE DETACHED FROM THE INSTRUCTION. FORCIBLY WITHDRAWING THE INSTRUMENT COULD CAUSE PATIENT INJURY SUCH AS PUNCTURES, HEMORRHAGES OR MUCOUS MEMBRANE DAMAGE." A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. PLEASE CROSS REFERENCE 8010047-2014-00387.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEM CORP. (OMSC) WAS INFORMED THAT DURING POLYPECTOMY, THE TWO DEVICES WERE USED AND THE CLIPS COULD NOT RELEASE ONCE DEPLOYED. THE EVENT WAS UNSPECIFIED BUT THERE WAS NO REPORT OF PATIENT INJURY REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416329 SINGLE USE ROTATABLE CLIP FIXING DEVICE CLIP FIXING DEVICE GDO OLYMPUS MEDICAL SYSTEMS CORPORATION HX-201UR-135L 32K

    Patients

    Seq Age Sex Outcome Treatment
    1