BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMOKE EVACUATOR RF SENSOR

    MDR report key: 16282839 · Received February 2, 2023

    Report

    Report Number
    1721194-2023-00033
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Date of Event
    January 17, 2023
    Report Date
    March 2, 2023
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    FYD
    UDI-DI
    10614559104644
    PMA / PMN Number
    K200250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/2/2023. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE 2255J WAS RETURNED WITH NO APPARENT DAMAGE. THE SENSOR WAS CONNECTED TO A GENERATOR AND INTERMITTENT ACTIVATION WAS FOUND. NO CONTINUOUS ACTIVATION WAS NOTED DURING THE ANALYSIS. AS PART OF ETHICON ENDO SURGERY QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT. MANUFACTURING RECORD EVALUATION IS NOT REQUIRED AS THE REPORTED EVENT IS NOT ASSOCIATED WITH THE MANUFACTURING PROCESS AND/OR THE POTENTIAL CAUSE OF THE DEFECT CANNOT BE ASSOCIATED TO MANUFACTURING. LOT: 002140; DEVICE HISTORY REVIEW: NULL.

    Additional Manufacturer Narrative · 0

    PC-(B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO LOT NUMBER WAS PROVIDED THEREFORE A DEVICE HISTORY COULD NOT BE DONE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN TESTING IT WAS FOUND THAT THE RF SENSOR CAUSES THE UNIT TO RUN CONTINUOUSLY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400427 SMOKE EVACUATOR RF SENSOR MEGADYNE¿ RF SENSOR FYD MEGADYNE MEDICAL PRODUCTS, INC. 2255J 10614559104644

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown