BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYPECTOMY SNARE

    MDR report key: 369945 · Received December 20, 2001

    Report

    Report Number
    369945
    Event Type
    Injury
    Date Received
    December 20, 2001
    Date of Event
    December 13, 2001
    Report Date
    December 19, 2001
    Manufacturer
    TELEMED SYSTEMS, INC
    Product Code
    FDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SNARE ELECTROCAUTERY DURING A POLYPECTOMY THE SNARE WAS NOTED TO NOT CUT CLEANLY RESULTING IN UNEXPECTED BLEEDING AT SITE. SNARE WAS REMOVED AND NOTED TO BE TWISTED LEAVING AN IRREGULAR CUTTING EDGE OF LOOP. SITE REQUIRED FURTHER CAUTERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57947 POLYPECTOMY SNARE SAME FDI TELEMED SYSTEMS, INC * K01484004

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention