BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASTIC PROCEDURE

    MDR report key: 10684756 · Received October 15, 2020

    Report

    Report Number
    3005011024-2020-00004
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    July 1, 2020
    Report Date
    September 22, 2021
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LRO
    UDI-DI
    00749756281379
    PMA / PMN Number
    K842648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE BOVIE TIP SUPPLIER COVIDIEN. ROOT CAUSE: COVIDIEN WAS UNABLE TO DETERMINE THE TRUE ROOT CAUSE, DUE TO LACK OF THE SAMPLE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS TAKEN BY COVIDIEN, BECAUSE THE ROOT CAUSE COULD NOT BE DETERMINED. PER SUPPLIER COVIDIEN, THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED TO ENSURE THE PRODUCT MEETS ITS QUALITY SPECIFICATIONS. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A MEDWATCH REPORT (UF/IMPORTER REPORT #4400150000-2020-8027) WAS RECEIVED INDICATING THAT A CAUTERY PENCIL CONTAINED WITHIN A CONVENIENCE KIT (PART 89-2575, LOT 52183443) MALFUNCTIONED DURING USE. INITIALLY, A SAMPLE WAS REPORTED TO BE AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THAT SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE BILL OF MATERIALS (BOM) IDENTIFIED THAT THE AFFECTED KIT COMPONENT WAS 5-19017, A PUSH BUTTON CAUTERY PENCIL. THIS RAW MATERIAL IS SUPPLIED TO DEROYAL BY COVIDIEN. THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) LOG WAS REVIEWED TO DETERMINE IF SIMILAR ISSUES HAVE BEEN REPORTED PREVIOUSLY. THERE HAVE BEEN PREVIOUS REPORTED ISSUES FOR THE SAME RAW MATERIAL. THEREFORE, A SCAR WAS ISSUED TO COVIDIEN AND IS DUE 10/30/2020. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. A RAW MATERIAL INSPECTION OF THE AVAILABLE LOTS IN INVENTORY WAS CONDUCTED. NO RAW MATERIAL WAS FOUND TO BE DEFECTIVE. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE CAUTERY PENCIL WAS PLUGGED INTO AN FT10 UNIT. THE SURGEON ACTIVATED THE PENCIL, AND RELEASED THE BUTTON. AFTER RELEASING THE BUTTON, THE PENCIL CONTINUED TO OPERATE. THE PENCIL CONTINUED TO MALFUNCTION AFTER BEING SWITCHED FROM MONOPOLAR 1 TO MONOPOLAR 2. EVENTUALLY, IT WAS SWITCHED OUT WITH A DIFFERENT PRODUCT. THE CAUTERY PENCIL WAS PACKAGED IN A CONVENIENCE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148065 PLASTIC PROCEDURE GENERAL SURGERY TRAY LRO DEROYAL INDUSTRIES, INC. 89-2575 51283443 00749756281379

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR