BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS SD-9U

    MDR report key: 22486 · Received January 18, 1995

    Report

    Report Number
    2429304-1994-01532
    Event Type
    Injury
    Date Received
    January 18, 1995
    Date of Event
    November 11, 1994
    Report Date
    November 14, 1994
    Manufacturer
    OLYMPUS OPTICAL CO., LTD.
    Product Code
    FDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A COLONOSCOPY, THE SNARE BROKE AND SPRANG OPEN TOUCHING THE WALL OF THE COLON. THE CURRENT WAS STILL TURNED ON WHEN THE SNARE TOUCHED THE COLON WALL, AND THEREBY CAUSED A PEERFORATION. THE PT WAS TAKEN TO SURGERY TOHAVE THE PERFORATION REPAIRED, AND IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SD-9U REUSABLE SNARE FDJ OLYMPUS OPTICAL CO., LTD. SD-9U UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention