BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR3 GENERATOR *EA

    MDR report key: 9111504 · Received September 24, 2019

    Report

    Report Number
    1221934-2019-58486
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    August 25, 2019
    Report Date
    August 27, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705009107
    PMA / PMN Number
    K113545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED AT THE SERVICE CENTER. THE DEFECT REPORTED BY THE CUSTOMER HAS BEEN VERIFIED AND REPAIRED. ON INSPECTING THE DEVICE, THE RF BOARD WAS DAMAGED AND WAS REPLACED. THE EXACT ROOT CAUSE IS DEFECTIVE RF BOARD. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 1221818 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE SERVICE HISTORY OF THE GENERATOR WAS CHECKED, AND NO ABNORMALITY WAS FOUND. GA TEST AND ELECTRICAL SAFETY TEST WERE PASSED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING THE DEMO, WHEN START THE VAPR3 GENERATOR, IT SHOWS ALERT CODE 200.12. IT WILL BE REPAIRED IN (B)(4) CTS, NOT RETURN TO (B)(4). THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. IT IS JJMS COMMERCIAL SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903386 VAPR3 GENERATOR *EA ELECTROSURGICAL SYSTEM GENERATOR GEI DEPUY MITEK LLC US 10886705009107

    Patients

    Seq Age Sex Outcome Treatment
    1