BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR3 GENERATOR *EA

    MDR report key: 10587799 · Received September 25, 2020

    Report

    Report Number
    1221934-2020-02746
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    September 10, 2020
    Report Date
    September 10, 2020
    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

    PRODUCT COMPLAINT #: (B)(4). 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 AT THE SERVICE CENTER AND EVALUATED. IT WAS REPORTED THAT THE DEVICE GAVE AN ERROR CODE 200 12. PER SERVICE MANUAL OPERATIONAL AND DIAGNOSTIC, THIS COMPLAINT CAN BE CONFIRMED. IT WAS FOUND DURING EVALUATION THAT THE IDT BOARD WAS DEFECTIVE. IT WAS REPLACED TO RESOLVE THE ISSUE. AFTER REPAIR, THE DEVICE WAS FOUND TO BE WORKING ACCORDING TO THE SPECIFICATIONS. THE DEFECTIVE IDT BOARD IS IDENTIFIED AS THE ROOT CAUSE OF THE REPORTED PROBLEM. WITH THE AVAILABLE INFORMATION, WE CANNOT DETERMINE HOW THE IDT BOARD BECAME DEFECTIVE. THE SERVICE HISTORY HAS BEEN REVIEWED IN LIEU OF THE DEVICE HISTORY RECORD FOR THIS DEVICE SINCE IT WAS PREVIOUSLY SERVICED. THE DEVICE WAS LAST SERVICED ON 08/20/2019 AND PASSED ALL FUNCTIONAL TESTING BEFORE BEING RETURNED TO THE CUSTOMER. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, 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 THAT DURING THE SURGERY OF ACL TEAR, WHEN START THE DEVICE, IT SHOWS ALERT CODE 200.12. IT WILL BE REPAIRED IN CHINA CTS, NOT RETURN TO OPOC. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053412 VAPR3 GENERATOR *EA ELECTROSURGICAL SYSTEM GENERATOR GEI DEPUY MITEK LLC US 225021 10886705009107

    Patients

    Seq Age Sex Outcome Treatment
    1