BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ROTATABLE CLIP FIXING DEVICE

    MDR report key: 3944345 · Received May 8, 2014

    Report

    Report Number
    8010047-2014-00239
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 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 DEVICE HAVE NOT BEEN 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 AN ABUNDANCE OF CAUTION. PLEASE CROSS REFERENCE: 8010047-2014-00237/00238/00240/00241.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEM CORP. (OMSC) WAS INFORMED THAT DURING UNIDENTIFIED PROCEDURE, FIVE CLIPS DID NOT OPEN PROPERLY AND THE DOCTOR FAILED TO DEPLOY THE CLIPS. THE DOCTOR COMPLETED THE PROCEDURE WITH SEVERAL MORE CLIPS FROM A SEPARATE BOX. THERE WAS NO REPORT OF PT INJURY REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278092 SINGLE USE ROTATABLE CLIP FIXING DEVICE CLIP FIXING DEVICE GDO OLYMPUS MEDICAL SYSTEMS CORPORATION HX-201UR-135L 3XK

    Patients

    Seq Age Sex Outcome Treatment
    1