BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR VUE GENERATOR

    MDR report key: 8282749 · Received January 28, 2019

    Report

    Report Number
    1221934-2019-56181
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    May 16, 2016
    Report Date
    May 16, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705009121
    PMA / PMN Number
    K113545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 HAS BEEN VERIFIED AND REPAIRED. SERVICE CENTER RECORD (B)(4). FAULT CONFIRMED. THE FOLLOWING REPAIR ACTIVITIES WERE PERFORMED REPLACED POWER SUPPLY BOARD - FAULTY. PERFORMED FULL CONFORMANCE TEST AS PER TEST RECORD (B)(4) - ALL TESTS PASS, AND ELECTRICAL SAFETY TESTED - PASS. A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED ONE OTHER SIMILAR COMPLAINT 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: 1220575; QTY OF LOT: (B)(4); RELEASE TO WAREHOUSE DATE: 3/9/2012; MANUFACTURING DATE: 3/9/2012; EXPIRATION DATE: N/A; SUPPLIER: (B)(4). MANUFACTURING SITE: (B)(4); ANY ANOMALIES OR DISCREPANCIES IN THE MANUFACTURE OF THE LOT: NO. 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 THE VAPR VUE GENERATOR BEING TESTED DAY BEFORE PROCEDURE AND WHEN GENERATOR CONNECTED TO POWER, IT WOULD NOT SWITCH ON. IT DID NOT AFFECT PROCEDURE FOLLOWING DAY AS REPLACEMENT GENERATOR AVAILABLE. THERE WAS NO PATIENT HARM OR SURGICAL DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74732 VAPR VUE GENERATOR ELECTROSURGICAL SYSTEM GENERATOR GEI DEPUY MITEK LLC US 10886705009121

    Patients

    Seq Age Sex Outcome Treatment
    1