BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1" BLADE ELECTRODE

    MDR report key: 6372272 · Received March 2, 2017

    Report

    Report Number
    1060680-2017-00008
    Event Type
    Malfunction
    Date Received
    March 2, 2017
    Date of Event
    January 24, 2017
    Report Date
    March 21, 2017
    Manufacturer
    MODERN MEDICAL EQUIPMENT MANUFACTURING LTD.
    Product Code
    HGI
    PMA / PMN Number
    K952030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE ELECTRODE IS SUPPLIED TO DEROYAL BY MODERN MEDICAL. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO MODERN MEDICAL. IN ITS RESPONSE, MODERN MEDICAL REVIEW AND TESTED RETAINED SAMPLES AND OBSERVED NO MELTING ON THE INSULATED TUBE OR ELECTRODE TIP. THEREFORE, THE ROOT CAUSE IS UNABLE TO BE DETERMINED. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, MODERN MEDICAL STATED IF THE DEFECTIVE SAMPLES OR ADDITIONAL INFORMATION IS RECEIVED, FURTHER ANALYSIS WILL BE TAKEN. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (CALL (B)(6)) WAS RECEIVED INDICATING A 1" BLADE ELECTRODE MELTED DURING USE. NO PATIENT HARM WAS REPORTED. ON FEBRUARY 23, 2017, DEROYAL RECEIVED NOTICE OF A MEDWATCH REPORT FROM THE FDA. A SAMPLE INITIALLY WAS REPORTED TO BE AVAILABLE. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RECEIVED. A DEROYAL SALES REPRESENTATIVE HAS BEEN IN CONTACT WITH THE REPORTING CUSTOMER, AND IF THE SAMPLE IS RECEIVED, THE COMPLAINT INVESTIGATION WILL BE REOPENED. THE WORK ORDER FOR THE REPORTED LOT NUMBER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. A SCAR WAS ISSUED TO MODERN MEDICAL AND A RESPONSE RECEIVED MARCH 3. DEROYAL QUALITY PERSONNEL HAS REVIEWED AND ACCEPTED THE RESPONSE. IN ITS RESPONSE, MODERN MEDICAL STATED FOUR SAMPLES FROM TWO LOTS WERE TESTED USING A BOVIE GENERATOR AT POWER SETTING 40 FOR 10 CYCLES (ONE CYCLE IS 10 SECONDS FOR CUT MODE AND 10 SECONDS FOR COAGULATION MODE). ALL SAMPLES PASSED WITHOUT ANY MELTING OCCURRING ON THE INSULATED TUBE OR THE ELECTRODE TIP. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING A 1" BLADE ELECTRODE MELTED DURING USE. NO PATIENT HARM WAS REPORTED. ON FEBRUARY 23, 2017, DEROYAL RECEIVED NOTICE OF A MEDWATCH REPORT FROM THE FDA. A SAMPLE INITIALLY WAS REPORTED TO BE AVAILABLE. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RECEIVED. THE ELECTRODE IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST WAS SUBMITTED FEBRUARY 22, 2017, TO (B)(4). AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. THE INVESTIGATION IS INCOMPLETE AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    INSULATED COATED ELECTROCAUTERY BLADES MELTED DURING USE. THE SETTINGS WERE SET AT COAG 40/CUT 40. THERE WAS NO APPARENT HARM TO THE PATIENT. THE DEVICE WAS IN USE WITH A CAUTERY MACHINE.

    Description of Event or Problem · 1

    INSULATED COATED ELECTROCAUTERY BLADES MELTED DURING USE. THE SETTINGS WERE SET AT COAG 40/CUT 40. THERE WAS NO APPARENT HARM TO THE PATIENT. THE DEVICE WAS IN USE WITH A CAUTERY MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157490 1" BLADE ELECTRODE ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) HGI MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. 88-000M13C 43105398

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR