BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SD-9U SET

    MDR report key: 97456 · Received June 11, 1997

    Report

    Report Number
    2429304-1997-00016
    Event Type
    Injury
    Date Received
    June 11, 1997
    Date of Event
    April 30, 1997
    Report Date
    June 3, 1997
    Manufacturer
    THE OLYMPUS OPTICAL CO.
    Product Code
    FDI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A POLYPECTOMY PROCEDURE, WHILE USING THE SD-9U SNARE AND A-CORD WITH A CON MED ELECTROSURGICAL UNIT, THE CON MED ELECTROSURGICAL UNIT DID NOT ACTIVATE. TISSUE BECAME ENTRAPPED IN THE SNARE CAUSING THE TISSUE AND A PIECE OF THE COLON TO BE PULLED OUT THROUGH THE RECTUM. AS A RESULT, THE SURGEON WAS REQUIRED TO DISSECT THE POLYP FROM THE COLON WALL IN ORDER TO RELEASE THE SNARE AND RETURN THE PIECE OF COLON BACK INTO THE PT. THE PT REMAINED IN THE HOSPITAL BUT WAS NOT REQUIRED TO STAY OVERNIGHT. AT THIS TIME, THE SURGEON DOES NOT KNOW IF PERMANENT INJURY TO THE PT WILL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SD-9U SET SD-9U DIATHERMIC SNARE SET FDI THE OLYMPUS OPTICAL CO. SD-9U NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention