BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE ELECTROSURGICAL SOFT OVAL SNARE

    MDR report key: 3874352 · Received April 18, 2014

    Report

    Report Number
    2951238-2014-00141
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 4, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K902735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN EVALUATED BY OLYMPUS. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A COLONOSCOPY PROCEDURE, THE SNARE WAS DEPLOYED TO REMOVE A POLYP AND ONCE THE POLYP WAS REMOVED, THE SNARE WAS RETRACTED PARTIALLY IN THE SHEATH AND USED TO CAUTERIZE A BLEEDER, WHICH IGNITED A SPARK AND ARCING WAS VISIBLE. THE SNARE WAS REMOVED FROM THE PT THROUGH THE SCOPE. IT WAS NOTED THAT THE WIRE WAS BURNED AND SEPARATED INTO TWO PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237900 DISPOSABLE ELECTROSURGICAL SOFT OVAL SNARE ELECTROSURGICAL SNARE GEI OLYMPUS MEDICAL SYSTEM CORPORATION SD-240U-10 V3X31

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR