BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ROTATABLE CLIP FIXING DEVICE

    MDR report key: 2504818 · Received March 21, 2012

    Report

    Report Number
    8010047-2012-00083
    Event Type
    Injury
    Date Received
    March 21, 2012
    Date of Event
    January 15, 2012
    Report Date
    February 21, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GDO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT #: 1YK, 1XK, 15K. THE DEVICES REFERENCED IN THIS REPORT WERE NOT RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED PHENOMENA COULD NOT BE CONCLUSIVELY DETERMINED. IF RELEVANT AND A SIGNIFICANT INFO WAS RECEIVED AT THE LATER TIME, THEN THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNIDENTIFIED PROCEDURE, THE REFERENCE CLIP WAS SAID TO HAVE BEEN ATTACHED TO THE DUODENAL VESSEL, BUT FAILED TO RELEASE. THE USER REPORTEDLY ATTEMPTED TO RELEASE THE DEVICE BY SHAKING THE SHEATH GENTLY WHICH REPORTEDLY CAUSED A TEAR IN THE PT'S VESSEL AND THE PT HAD TO BE TRANSPORTED TO SURGERY. ON ANOTHER OCCASION, THREE DAYS LATER, CLIPS WERE USED ON GASTRIC BLEED. THE FIRST THREE CLIPS REPORTEDLY WOULD NOT EXTEND FROM THE SHEATH AND THE OTHER CLIPS REPORTEDLY WOULD NOT OPEN AND APPEARED DAMAGED. A TOTAL OF EIGHT CLIPS WERE REPORTEDLY USED AND ONLY ONE WAS SAID TO BE SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE USE ROTATABLE CLIP FIXING DEVICE CLIP FIXING DEVICE GDO OLYMPUS MEDICAL SYSTEMS CORPORATION HX-201UR-135L.B 12K

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention