BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, 4" COATED BLADE

    MDR report key: 7512234 · Received May 14, 2018

    Report

    Report Number
    2320762-2018-00002
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    April 16, 2018
    Report Date
    May 14, 2018
    Manufacturer
    MODERN MEDICAL EQUIPMENT MANUFACTURING LTD
    Product Code
    HGI
    UDI-DI
    00749756338226
    PMA / PMN Number
    K952030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THIS IS THE FIRST TIME A REPORT OF THIS TYPE HAS BEEN RECEIVED FOR THIS PART NUMBER. THEREFORE, THIS INCIDENT HAS BEEN DETERMINED TO BE A RANDOM PART DEFECT. CORRECTIVE ACTION: DUE TO THE INVESTIGATION AND ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED INDICATING THAT A COATED ELECTRODE (PART NUMBER 88-000015C) FAILED DURING USE, ALLOWING ESCHAR TO STICK TO THE ELECTRODE TIP AND CREATING MORE BLEEDING. THE END USER DISCARDED THE PRODUCT; THEREFORE, THE DEFECTIVE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, A LOT NUMBER FOR THE AFFECTED PRODUCT WAS NOT PROVIDED. WITHOUT A LOT NUMBER, THE WORK ORDER COULD NOT BE REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. RAW MATERIAL INVENTORY FOR THE REPORTED FINISHED GOOD NUMBER WAS INSPECTED FOR ANY MISSING AND/OR DEFECTIVE PLACES IN THE BLADE COATING. NO DEFECTS WERE IDENTIFIED. BECAUSE THIS WAS THE FIRST REPORT OF ITS NATURE FOR THIS PART NUMBER, A SUPPLIER NOTIFICATION LETTER WAS SENT TO THE ELECTRODE MANUFACTURER, MODERN MEDICAL, TO NOTIFY THEM OF THE REPORTED ISSUE. FROM (B)(4) 2016 TO PRESENT, DEROYAL HAS SOLD (B)(4) CASES OR (B)(4) EACH FOR FINISHED GOOD 88-000015C. DURING THIS REVIEW PERIOD, ONLY ONE COMPLAINT (THE INCIDENT COVERED IN THIS REPORT) WAS RECEIVED FOR THIS PRODUCT. THIS EQUATES TO A COMPLAINT-TO-SALES RATIO OF 0.01 PERCENT. DEROYAL WILL CONTINUE TO MONITOR POSTMARKET FEEDBACK AND WILL RECOGNIZE IN THE FUTURE IF A TREND DEVELOPS. PREVENTIVE ACTION: DUE TO THE INVESTIGATION AND ROOT CAUSE DETERMINATION, A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ACCORDING TO THE ROOM STAFF, THE PROBLEM WITH THE CAUTERY TIP (SPECIFICALLY DEROYAL 4" TIP #(B)(4)) WAS THAT AFTER CAUTERIZATION OF TISSUE, WHEN TAKING PENCIL TIP OFF OF TISSUE, THE ESCHAR REMAINED STUCK TO THE CAUTERY PENCIL AND "TORE" AWAY FROM THE CAUTERIZED TISSUE RATHER THAN REMAINING ON THE TISSUE, THUS CREATING MORE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355636 ELECTRODE, 4" COATED BLADE ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) HGI MODERN MEDICAL EQUIPMENT MANUFACTURING LTD 88-000015C NOT PROVIDED 00749756338226

    Patients

    Seq Age Sex Outcome Treatment
    1