BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROGRESSIVE PUSH BUTTON PENCIL WITH PTFE BLADE

    MDR report key: 1852270 · Received January 22, 2010

    Report

    Report Number
    8040510-2009-00001
    Event Type
    Other
    Date Received
    January 22, 2010
    Date of Event
    June 3, 2009
    Report Date
    December 23, 2009
    Manufacturer
    MODERN MEDICAL EQUIPMENT MANUFACTURING LTD
    Product Code
    GEI
    PMA / PMN Number
    K936304
    Removal / Correction Number
    MW5013002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO OUR SALES DATA, THE ELECTROSURGICAL PENCIL WAS SOLD TO OUR CUSTOMER PROGRESSIVE IN A BULK QUANTITY, WITHOUT THE ELECTRODE. IT IS OUR CUSTOMER'S FREEDOM TO REPACK IN HIS PREFERENCE. THE ELECTRODE IN QUESTION WHICH CAUSED THE BURN WAS NOT MANUFACTURED BY OUR COMPANY.

    Description of Event or Problem · 1

    A TONSILLECTOMY AND ADENOIDECTOMY WAS PERFORMED ON A MALE WITHOUT INCIDENT UNTIL IT WAS DISCOVERED AT THE END OF THE PROCEDURE THAT THE PATIENT RECEIVED A BURN ON HIS RIGHT LIP. PICTURES WERE TAKEN OF THE BURN AND THE BOVIE WHICH WERE SECURED AND LABELED. ANTIBIOTIC OINTMENT WAS APPLIED AND THE PROCEDURE WAS TERMINATED. SEVERAL DAYS LATER, THE DOCTOR FILED A REPORT ADDENDUM STATING THAT THE BURN OCCURRED BECAUSE OF EXPOSED METAL TOUCHING THE LIP AND THE TIP WAS UNUSUALLY DIFFICULT TO INSERT INTO THE PENCIL, YET HE DECIDED TO USE IT ANYWAY. THE IFU CLEARLY STATED IN PART, THE FOLLOWING PRECAUTIONS: "SECURELY ATTACH ALL COMPONENTS PRIOR TO USE, CHECK THE ELECTRODE CONNECTION TO THE ACCESSORY YOU ARE USING TO ENSURE PROPER FIT AND COMPATIBILITY. IMPROPER ELECTRODE INSTALLATION MAY RESULT IN INJURY TO THE PATIENT OR OPERATING ROOM PERSONNEL BY ARCING AT THE ELECTRODE/PENCIL CONNECTION. EXAMINE ALL DEVICES TO BE CONNECTED TO THE ELECTROSURGICAL GENERATOR. AFTER CONNECTION, ENSURE THAT THEY ARE FUNCTIONING PROPERLY. BEFORE INSERTING OR CHANGING AN ELECTRODE, BE SURE THAT THE ACTIVE ACCESSORY IS NOT CONNECTED TO AN ELECTROSURGICAL GENERATOR, OR THAT THE GENERATOR IS OFF (STANDBY). GRASP THE ELECTRODE BY THE INSULATING SLEEVE, AND INSERT THE ROUND SHANK INTO THE ELECTROSURGICAL ACCESSORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRESSIVE PUSH BUTTON PENCIL WITH PTFE BLADE PUSH BUTTON ELECTROSURGICAL PENCIL GEI MODERN MEDICAL EQUIPMENT MANUFACTURING LTD 032409-03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AN ELECTROSURGICAL BLADE IS USED WITH THE| ELECTROSURGICAL PENCIL