BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-SECTION PACK

    MDR report key: 9122465 · Received September 26, 2019

    Report

    Report Number
    3005011024-2019-00012
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    July 31, 2019
    Report Date
    September 25, 2019
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    UDI-DI
    00749756980081
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: A ROOT CAUSE COULD NOT BE DETERMINED. NO ISSUES WERE IDENTIFIED DURING ANALYSIS OF PRODUCTION RECORDS. AN INSPECTION OF THE DEFECTIVE SAMPLE COULD NOT BE PERFORMED BECAUSE A SAMPLE WAS NOT RETURNED. IF THE DEFECTIVE SAMPLE IS RETURNED, THE CASE WILL BE REOPENED. CORRECTIVE ACTION: A CORRECTIVE ACTION WAS NOT TAKEN DUE TO THE ROOT CAUSE DETERMINATION. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED FOR A CONVENIENCE KIT (PART 89-10044, LOT 49860941) THAT CONTAINED AN ELECTROSURGICAL PENCIL THAT WOULD NOT WORK. THE END USER REPORTED THIS INCIDENT TO THE FDA (REPORT MW5088867). A DEFECTIVE SAMPLE INITIALLY WAS REPORTED TO BE AVAILABLE FOR RETURN. HOWEVER, AS OF THE DATE OF THIS REPORT, A SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. THE WORK ORDER FOR THE REPORTED FINISHED GOOD LOT NUMBER WAS REVIEWED FOR POSSIBLE DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE BILL OF MATERIALS FOR THE FINISHED GOOD KIT WAS REVIEWED AND (B)(4) WAS IDENTIFIED AS THE ELECTROSURGICAL PENCIL CONTAINED WITHIN THE KIT. THIS PENCIL IS MANUFACTURED AT DEROYAL (B)(4). THE INVESTIGATOR AT THE (B)(4) FACILITY REVIEWED THE PRODUCTION RECORDS FOR THE FINISHED PENCIL AND ITS SUB-ASSEMBLY. NO DISCREPANCIES WERE IDENTIFIED. PRODUCT IN-PROCESS AT (B)(4) WAS INSPECTED. EIGHTY UNITS WERE INSPECTED USING A CONTINUITY TEST AND ALL UNITS WERE ACCEPTED. FROM 2017 TO PRESENT, THREE COMPLAINTS HAVE BEEN RECEIVED FOR ELECTROSURGICAL PENCILS EXHIBITING A SIMILAR ISSUE. HOWEVER, THE PART NUMBERS ASSOCIATED WITH THESE COMPLAINTS WERE DIFFERENT THAN THE ONE CURRENTLY UNDER INVESTIGATION. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE ELECTROSURGICAL PENCIL THAT WAS PACKAGED IN A CONVENIENCE KIT WOULD NOT WORK. AFTER CHECKING THE MACHINE TO ENSURE IT WAS WORKING, A NEW PENCIL WAS OPENED AND WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918430 C-SECTION PACK DISPOSABLE SURGICAL INSTRUMENT KIT KDD DEROYAL INDUSTRIES, INC. 89-10044 49860941 00749756980081

    Patients

    Seq Age Sex Outcome Treatment
    1