BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL GENERATOR

    MDR report key: 18698238 · Received February 13, 2024

    Report

    Report Number
    1721194-2024-00015
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 1, 2024
    Report Date
    March 8, 2024
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559105597
    PMA / PMN Number
    K193145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 2/22/20204. ADDITIONAL INFORMATION RECEIVED: THE ELECTROSURGICAL GENERATOR WITH PRODUCT CODE MEGEN 1 AND S/N (B)(6) IS MALFUNCTIONING AND THE SPECIFIC SYMPTOM IS CRUCIAL FOR THE PATIENT SAFETY. THE PROBLEM IS THAT THE ALARM OF THE ES GENERATOR IS NOT WORKING AT ALL. FOR EXAMPLE: WHEN THE PATIENT RETURN ELECTRODE (REGARDLESS MANUFACTURER, WE USED MEGASOFT 0845 AND 0855CL) IS NOT CONNECTED TO THE MEGEN1 THE ALARM IS GREEN AND THIS MEANS THAT IS WORKING NORMALLY. SO, WHEN WE CONNECT AN ACTIVE ELECTRODE (0035H) TO THE MEGEN1 IT IS WORKING, EVEN THE FACT THAT, THE RETURN ELECTRODE IS NOT CONNECTED TO THE GENERATOR. WERE THERE ANY PATIENT CONSEQUENCES? NO.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/8/2024. INVESTIGATION SUMMARY: PER SERVICE MANUAL OPERATIONAL AND DIAGNOSTIC ANALYSIS DID NOT CONFIRM THE REPORTED THE SELF ACTIVATION. THE UNIT PASSED ALL FUNCTIONAL TESTS AND IS FULLY OPERATIONAL. NO FURTHER INVESTIGATION WILL BE CONDUCTED ON THIS COMPLAINT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND CERTED BY EXTERNAL MANUFACTURING THAT THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THE EQUIPMENT. THE CERTIFICATE RECORDS ARE ACCESSIBLE THROUGH EXTERNAL MANUFACTURING.

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 2/13/2024 B3: ONLY EVENT YEAR KNOWN: 2024 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. SERIAL NUMBER WAS RECEIVED AND DHR IS PENDING REVIEW. WHEN THE REVIEW IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT WITH A SUMMARY OF THE EVALUATION. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: WERE THERE ANY PATIENT CONSEQUENCES? 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 WE REMOVE THE PATIENT RETURN ELECTRODE, NEITHER THE ALARM SOUND IS ACTIVATED, NOR DOES THE LIGHT TURN RED. MOREOVER, THE MONOPOLAR ELECTRODE CONTINUES TO WORK EVEN THOUGH THE PATIENT RETURN ELECTRODE HAS NOT BEEN INSERTED INTO THE RECEPTACLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781090 ELECTROSURGICAL GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEGADYNE MEDICAL PRODUCTS, INC. 10614559105597

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown