BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLORADO

    MDR report key: 3113361 · Received May 2, 2013

    Report

    Report Number
    3113361
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 2, 2013
    Manufacturer
    STRYKER LEIBINGER, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    THERE WAS A BURN TO A PATIENT BECAUSE THE BOVIE SETTING WAS HIGHER THAN RECOMMENDED. THE SUPERVISOR DISCUSSED THIS ISSUE WITH THE SURGEON'S PRIVATE SCRUB AND TOLD HER WE WILL NO USE A SETTING OUTSIDE OF THE RECOMMENDATIONS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193552 COLORADO ELECTROSURGICAL, CUTTING, COAGULATION GEI STRYKER LEIBINGER, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *