BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR GENERATOR

    MDR report key: 1872397 · Received October 11, 2010

    Report

    Report Number
    1221934-2010-00346
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED BOTH VISUALLY AND FUNCTIONALLY. ESTHETICALLY, THE DEVICE WAS, OUTSIDE OF SOME MINOR CHASSIS SCRATCHES AND CHIPS TO THE FASCIA, IN GOOD APPEARANCE. FUNCTIONALLY THE DEVICE PASSED ALL TEST, FUNCTIONED WELL WITHIN ITS DESIGNED AND MANUFACTURED SPECIFICATIONS; COULD NOT DUPLICATE THE REPORTED ISSUE AND COULD FIND NO FAULT WITH THE DEVICE. WE CANNOT DISCERN THE UNDERLYING CAUSE FOR THE REPORTED ISSUE. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED, HOWEVER, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE GENERATOR IS HAVING INTERMITTENT ACTIVATION AND IS CAUSING A MONITOR SCREEN TO FLUCTUATE; EACH TIME THAT THE FOOT PEDAL WAS DEPRESSED, THE MONITOR'S SCREEN WOULD BECOME TOTALLY FUZZY. A SECOND GENERATOR WAS EMPLOYED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. THE PROCEDURE WAS EXTENDED BY LESS THAN 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPR GENERATOR ELECTROSURGICAL; CUTTING AND COAGULATING GEI DEPUY MITEK 225021 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK