BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS SIGNLE USE ROTATABLE CLIP FIXING DEVICE

    MDR report key: 2495969 · Received March 14, 2012

    Report

    Report Number
    8010047-2012-00072
    Event Type
    Injury
    Date Received
    March 14, 2012
    Date of Event
    January 15, 2012
    Report Date
    February 14, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT LOT NUMBER OF THE CLIP FIXING DEVICE USED DURING THE PROCEDURE WAS NOT PROVIDED; THE FOLLOWING LOT NUMBERS HAD BEEN ORDERED BY THE USER FACILITY: 12K, 1YK, OR 15K. HOWEVER, IT IS UNKNOWN WHICH LOT NUMBERS WERE ACTUALLY USED DURING THE PROCEDURE. A REVIEW OF THE MANUFACTURING HISTORY OF THE DEVICE FROM THE SAME LOT UMBER REVEALED NO IRREGULARITIES DURING THE MANUFACTURING OF THE SUBJECT DEVICE. THE CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME, BUT USER ERROR COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR TO THE REPORTED EVENT. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE PROVIDED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC GASTROSCOPY FOR BLEEDING DUODENAL ULCER, THE USER ATTEMPTED TO ATTACH A CLIP TO THE DUODENAL VESSEL, BUT THE CLIP WOULD NOT RELEASE. THE USER ATTEMPTED TO RELEASE THE CLIP FROM THE HOOK BY SHAKING THE SHEATH GENTLY BUT THIS CAUSED A TEAR IN THE VESSEL AND BLEEDING THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS TAKEN TO THE SURGERY ROOM FOR MEDICAL AND SURGICAL INTERVENTION. THE PATIENT WAS DISCHARGED AFTER SEVEN DAYS. THE PATIENT IS REPORTEDLY IN A STABLE CONDITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR OLYMPUS CORP GASTROINTESTINAL VIDEOSCOPE:| MODEL GIF-1T240, SERIAL NUMBER NOT REPORTED.