BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR VUE GENERATOR

    MDR report key: 8284672 · Received January 29, 2019

    Report

    Report Number
    1221934-2019-56193
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    October 14, 2016
    Report Date
    October 14, 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

    PRODUCT COMPLAINT # (B)(4). THE DEFECT HAS BEEN VERIFIED AND REPAIRED. THE FOLLOWING REPAIR 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. THE UNIT WAS EVALUATED AND THE CUSTOMER'S COMPLAINT OF AN INTERMITTENT CONNECTION WAS CONFIRMED. THE 8 WAY SOCKET ASSY WAS REPLACED TO REPAIR THE ISSUE. THE SCRATCHED TOP PLATE AND THE MISSING DUST COVER WERE REPLACED. 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. A DEVICE HISTORY RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT; THEREFORE, THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES ON THE PAPERWORK REVIEWED. 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: 1220492; RELEASE TO WAREHOUSE DATE: 3/5/12; MANUFACTURING DATE: 3/5/12; EXPIRATION DATE: N/A; SUPPLIER: (B)(4); MANUFACTURING SITE: (B)(4); NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS REPORT IS BEING FILED FROM THE (B)(4) AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VAPR VUE GENERATOR WORKED INTERMITTENTLY AND WOULD NOT RECOGNIZE THE WAND DURING A ROTATOR CUFF SURGERY. THERE WAS NO REPORTED PATIENT HARM OR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80095 VAPR VUE GENERATOR ELECTROSURGICAL SYSTEM GENERATOR GEI DEPUY MITEK LLC US 10886705009121

    Patients

    Seq Age Sex Outcome Treatment
    1