BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYPUS DISPOSABLE ELECTROSURGICAL SNARE

    MDR report key: 3592572 · Received January 2, 2014

    Report

    Report Number
    2951238-2013-00139
    Event Type
    Other
    Date Received
    January 2, 2014
    Date of Event
    December 5, 2013
    Report Date
    December 5, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BUT USER ERROR COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR TO THE REPORTED EVENT. THE USER FACILITY USED A NON-OLYMPUS ELECTROSURGICAL UNIT, WHICH IS NOT RECOMMENDED OR SUPPORTED BY OLYMPUS. IN ADDITION, THE DEVICE WAS USED TO FULGURATE AS OPPOSED TO RESECTION. THE DEVICE INSTRUCTIONS MANUAL WARNS USERS TO USE THE SNARE ONLY IN COMBINATION WITH THE PRODUCTS RECOMMENDED BY OLYMPUS. IF COMBINED WITH PRODUCTS NOT RECOMMENDED BY OLYMPUS, PT OR OPERATOR INJURY, MALFUNCTION OR EQUIPMENT DAMAGE MAY RESULT.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE SNARE WAS USED TO FULGURATE A POLYP BY USING THE TIP TO FULGURATE AT THE BASE. WHEN THE PHYSICIAN OPENED THE SNARE COMPLETELY, THE SNARE WAS BROKEN, AND THE PHYSICIAN SAW A FLASH AND ARCING INSIDE THE PT'S COLON. THE PHYSICIAN NOTED A DISCOLORATION IN THE MUCOSA AFTER THE FLASH. HOWEVER, THE PHYSICIAN STATED THAT THIS AREA GRADUALLY RETURNED TO NORMAL COLOR, AS THE DARK SPOT FADED. THE SNARE WAS WITHDRAWN FROM THE PT. THE PROCEDURE WAS COMPLETED USING AN UNIDENTIFIED INSTRUMENT. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2648 OLYPUS DISPOSABLE ELECTROSURGICAL SNARE SOFT OVAL SNARE FCL OLYMPUS MEDICAL SYSTEM CORP SD-24OU-25 29V

    Patients

    Seq Age Sex Outcome Treatment
    1 ELECTROSURGICAL UNIT - PFIZER VALLEYLAB FORCE 1C