BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ROTATABLE CLIP FIXING DEVICE

    MDR report key: 3823113 · Received January 20, 2014

    Report

    Report Number
    8010047-2014-00033
    Event Type
    Malfunction
    Date Received
    January 20, 2014
    Date of Event
    December 23, 2013
    Report Date
    December 23, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR INVESTIGATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADD'L AND SIGNIFICANT INFO BECOMES AVAILABLE AT A LATER TIME. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE DEVICES MISFIRED ON SEVERAL PROCEDURES. THE FIRST TWO OCCASIONS WERE WITH A RELATIVELY INEXPERIENCED STAFF, BUT THE SAME EVENT OCCURRED AGAIN WITH AN EXPERIENCED STAFF. THERE WAS NO PATIENT INJURY REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46614 SINGLE USE ROTATABLE CLIP FIXING DEVICE CLIP FIXING DEVICE GDO OLYMPUS MEDICAL SYSTEMS CORPORATION HX-201UR-135L 38K

    Patients

    Seq Age Sex Outcome Treatment
    1