BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR VUE GENERATOR

    MDR report key: 8281560 · Received January 28, 2019

    Report

    Report Number
    1221934-2019-56155
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Report Date
    January 29, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705009121
    PMA / PMN Number
    K113545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEFECT REPORTED COULD NOT BE VERIFIED. THE FOLLOWING ACTIVITIES WERE PERFORMED SERVICE & REPAIR FUNCTIONS AS PER (B)(4). NOTHING NOTED IN THE SERVICE HISTORY THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. ATTACHED BOX LABEL, ELECTRICAL SAFETY AND VAPR VUE REPAIR RECORD. COULD NOT DUPLICATE THE CUSTOMER'S COMPLAINT OF INTERMITTENT OPERATION. UNIT WAS EVALUATED, MANY ATTEMPTS OF TESTING, AND DIAGNOSTICS WERE MADE, NO PROBLEM WAS FOUND. THE TESTING OF THE UNIT WAS COMPLETED PER THE SERVICE MANUAL. THE UNIT PASSED ALL FUNCTIONAL TESTS AND IS FULLY OPERATIONAL. A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS DEVICE'S SERIAL NUMBER. 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. DHR REVIEW: PART NUMBER: 225024; SUPPLIER LOT NUMBER: 1220450; QTY OF LOT: (B)(4); RELEASE TO WAREHOUSE DATE: 2/22/2012; MANUFACTURING DATE: 2/22/2012; EXPIRATION DATE: N/A; SUPPLIER: (B)(4); MANUFACTURING SITE: (B)(4); ANY ANOMALIES OR DISCREPANCIES IN THE MANUFACTURE OF THE LOT: NO ANOMALIES OR DISCREPANCIES FOUND. THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN VAPR VUE GENERATOR HAD ISSUES CONNECTING TO FOOT PEDAL AND WANTS. DIFFERENT WANDS WERE USED AND RESULTED IN THE SAME ISSUE. THERE WAS NO PATIENT HARM REPORTED AND NO SURGICAL DELAY. SURGERY WAS COMPLETED WITH ANOTHER UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76006 VAPR VUE GENERATOR ELECTROSURGICAL SYSTEM GENERATOR GEI DEPUY MITEK LLC US 10886705009121

    Patients

    Seq Age Sex Outcome Treatment
    1