BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR3 GENERATOR *EA

    MDR report key: 9835819 · Received March 16, 2020

    Report

    Report Number
    1221934-2020-00859
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    January 1, 2020
    Report Date
    March 2, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.LE 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 WAS SHOWING INTERNAL FAILURE ERROR CODE 200 REFERENCE 12. PER SERVICE MANUAL OPERATIONAL AND DIAGNOSTIC, THIS COMPLAINT CAN BE CONFIRMED. DURING EVALUATION, THE ERROR CODE 200 WAS OBSERVED AND THE DEVICE FAILED ELECTRICAL SAFETY TEST. FURTHER, FOUR MOUNTING FEET WERE MISSING AND THE IDT BOARD WAS DISCONNECTED FROM THE RF BOARD. COSMETIC ISSUES WERE ALSO IDENTIFIED. THE ISSUES WERE RESOLVED BY RE-SEATING THE IDT BOARD AND BY REPLACING THE MOUNTING FEET AND POWER SUPPLY. AFTER REPAIR, THE DEVICE WAS FOUND TO BE WORKING ACCORDING TO THE SPECIFICATIONS. THE IDT BOARD BEING DISCONNECTED FROM THE RF BOARD IS IDENTIFIED AS THE ROOT CAUSE OF THE REPORTED PROBLEM OF THE ERROR CODE 200. THE DEFECTIVE POWER SUPPLY MIGHT HAVE CAUSED THE DEVICE TO FAIL THE ELECTRICAL SAFETY TEST. USER MISHANDLING AND/OR LACK OF MAINTENANCE CAN BE THE MOST PROBABLE ROOT CAUSES OF THE MISSING MOUNTING FEET AND OBSERVED COSMETIC ISSUES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE SERIAL NUMBER ((B)(6)), AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. 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. DEVICE HISTORY LOT A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE SERIAL NUMBER ((B)(6)), AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    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. H10 ADDITIONAL NARRATIVE: D10, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. 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). UDI: (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE BIO-MED DEPARTMENT VIA PHONE, THE VAPR III WAS SHOWING INTERNAL FAILURE ERROR CODE 200 REFERENCE 12 DURING A PLANNED MAINTENANCE CHECK. NO CASE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300016 VAPR3 GENERATOR *EA ELECTROSURGICAL SYSTEM GENERATOR GEI DEPUY MITEK LLC US 225021 10886705009107

    Patients

    Seq Age Sex Outcome Treatment
    1