BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3921379 · Received July 3, 2014

    Report

    Report Number
    3921379
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 3, 2014
    Manufacturer
    OLYMPUS CORPORATION OF THE AMERICAS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP BROKE OFF DURING CASE THREE TIMES. ADDITIONAL CHARGES AND TIME, NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391972 * ELECTROSURGICAL, CUTTING AND COAGULATION GEI OLYMPUS CORPORATION OF THE AMERICAS * 13319P02L001
    391973 * ELECTROSURGICAL, CUTTING AND COAGULATION GEI OLYMPUS CORPORATION OF THE AMERICAS * 13319P02L001
    391974 * ELECTROSURGICAL, CUTTING AND COAGULATION GEI OLYMPUS CORPORATION OF THE AMERICAS * 13319P02L001

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR