BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR3 GENERATOR *EA

    MDR report key: 8195749 · Received December 26, 2018

    Report

    Report Number
    1221934-2018-55810
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    May 1, 2018
    Report Date
    July 19, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705009107
    PMA / PMN Number
    K113545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AWARENESS DATE REPORTED ON INITIAL REPORT AS JULY 19, 2018 BUT SHOULD HAVE BEEN DECEMBER 21, 2018. 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.

    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 DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. OPERATIONAL AND DIAGNOSTIC ANALYSIS CONFIRMED REPORTED ISSUE. 200 REF 32 ERROR CODE WAS DISPLAYED DURING TESTING. THIS WAS DUE TO A BAD IDT BOARD. REPLACED THE IDT BOARD AS IDENTIFIED IN THE INVESTIGATION TO ADDRESS THE REPORTED ISSUE. NO ADDITIONAL ISSUE WAS FOUND. THE REPAIR AND TESTING OF THE UNIT WAS COMPLETED BY BRINGING THE UNIT BACK TO FULL FUNCTIONALITY. THE UNIT PASSED ALL FUNCTIONAL TESTS AND IS FULLY OPERATIONAL. THIS COMPLAINT IS CONFIRMED. THE ROOT CAUSE FOR THE REPORTED FAILURE WAS A BAD IDT BOARD. 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 BY THE SALES REPRESENTATIVE THAT THE VAPR DAMAGED. THE FOLLOWING WAS STATED ON THE VENDOR'S REPORT: "I HONESTLY DID NOT REGISTER THE ERROR CODE NUMBER BECAUSE IT WAS IN THE SURGERY, BUT I DO KNOW THAT I GAVE THE CODE AS SOON AS THE VAPR CONSOLE WAS TURNED ON. AND BECAUSE THE ERROR DID NOT WORK THE CONSOLE". PRODUCT INFORMATION: CODE: (B)(4) LOT: 1122742, SERIAL NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034432 VAPR3 GENERATOR *EA ELECTROSURGICAL SYSTEM GENERATOR GEI DEPUY MITEK LLC US 10886705009107

    Patients

    Seq Age Sex Outcome Treatment
    1