BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOOP CUTTER

    MDR report key: 3170475 · Received May 24, 2013

    Report

    Report Number
    8010047-2013-00125
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAVE NOT BEEN RETURNED TO OMSC FOR EVALUATION AT PRESENT. IF REPORTABLE RESULT IS FOUND AFTER THE EVALUATION, OMSC WILL SUBMIT THE RESULT AS SUPPLEMENTAL REPORT. OMSC REVIEWED THE MANUFACTURING RECORDS OF A PERIOD, WHEN THE SUBJECT DEVICE WAS SUPPOSED TO BE MANUFACTURED, AND CONFIRMED THAT THERE WAS NO IRREGULARITY. THE DEVICE INSTRUCTION MANUAL WARNS USERS THAT "DO NOT USE THE INSTRUMENT TO CUT ANY OBJECTS OTHER THAN THE SURPLUS OF OLYMPUS LOOP (E.G., MAJ-254, MAJ-340). IF ANYTHING OTHER THAN THE SURPLUS OF THE LOOP IS CUT, THE BLADES MAY BE DAMAGED AND UNABLE TO PERFORM PROPERLY, THE CUT OBJECT MAY BE CAUGHT IN THE TIP OF THE INSTRUMENT, AND IT MAY BECOME DIFFICULT TO SAFELY REMOVE THE INSTRUMENT FROM THE BODY. SUCH OBJECTS OTHER THAN THE SURPLUS OF LOOP MAY INCLUDE, STENT WIRE, SEWING THREADS, AND LOOP STOPPERS." THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPIC STENT PLACEMENT PROCEDURE FOR A BILIARY DUCT USING A METALLIC STENT, THE FILAMENT OF THE STENT BECAME STUCK IN THE TIP OF THE SUBJECT DEVICE AND COULD NOT BE RELEASED. THE EVENT REPORTEDLY OCCURRED WHEN THE USER ATTEMPTED TO CUT THE EXCESSIVE PORTION OF THE DUODENAL END OF THE STENT. IT WAS REPORTED THAT THE FACILITY COULD RELEASE THE STENT AND WITHDRAW THE SUBJECT DEVICE FROM THE PATIENT AFTER THEY OPERATED THE HANDLE OF THE SUBJECT DEVICE AND THE ENDOSCOPE. THERE WAS NO REPORT OF PATIENT INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230896 LOOP CUTTER LOOP CUTTER GEI OLYMPUS MEDICAL SYSTEMS CORPORATION FS-5Q-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK