BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL PUSH BUTTON PENCIL W/ENT

    MDR report key: 2051524 · Received March 9, 2011

    Report

    Report Number
    9613793-2011-00001
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    June 25, 2010
    Report Date
    June 25, 2010
    Manufacturer
    DEROYAL INDUSTRIES, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUTERY PENCIL REPORTED AS 'SPARKLING' UPON USE WAS RETURNED TO THE VENDOR OR INSPECTION. AN EVALUATION WAS COMPLETED WITHOUT THE ABILITY TO DETERMINE A ROOT CAUSE FOR THE REPORTED PROBLEM. THE VENDOR DETERMINED BY EVALUATION OF THE RETURNED DEVICE AND RECORDS REVIEW THAT THE PENCIL WAS MANUFACTURED ACCORDING TO SPECIFICATION AND PRODUCT MANUFACTURING PROCEDURES. TRENDING FILES WERE ALSO EXAMINED WITH NO FINDINGS PERTINENT TO THIS REPORTED PROBLEM.

    Description of Event or Problem · 1

    "WHEN USING THIS PRODUCT IN THE ORAL CAVITY TO REMOVE TONSILS, SPARKS ERUPTED FROM THE TIP OF THE BOVIE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL PUSH BUTTON PENCIL W/ENT ELECTROCAUTERY PENCIL GEI DEROYAL INDUSTRIES, INC 20558239

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention