BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGULR OLY LRG OVAL FIRM

    MDR report key: 304203 · Received November 8, 2000

    Report

    Report Number
    1223688-2000-00031
    Event Type
    Injury
    Date Received
    November 8, 2000
    Date of Event
    October 6, 2000
    Report Date
    October 12, 2000
    Manufacturer
    C.R. BARD, INC. BIPD DIV.
    Product Code
    KNS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN STATES SNARE WAS PLACED DOWN OLYMPUS CIF100L SCOPE INTO COLON FOR POLYP REMOVAL. USING A VALLEY LAB UNIT WITH SETTING AT 3-4 COAG MD PLACED SNARE LOOP OVER A 5CM POLYP, APPLIED CURRENT AND NOTED THE SNARE LOOP WAS "MATTED" TO THE POLYP AND COULD NOT BE REMOVED. MD CUT SHEATH FROM HAND AND REMOVED SCOPE FROM PT. MD SENT PT TO SURGERY TO HAVE POLYP AND SNARE LOOP REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGULR OLY LRG OVAL FIRM SNARE KNS C.R. BARD, INC. BIPD DIV. 61 000963 88GJ0554

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention