BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR VIEW FOOTSWITCH

    MDR report key: 2140593 · Received June 27, 2011

    Report

    Report Number
    1221934-2011-00251
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 24, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K100638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND TESTED. THE DEVICE WAS IN GOOD COSMETIC CONDITION; OUTSIDE OF SOME MINOR SCRATCHES THERE WAS NO DAMAGE OR ANOMALIES. FUNCTIONALLY, THE DEVICE PROVED FAULTY. THE TESTING CONFIRMED THAT THE DEVICE CONTINUED TO ACTIVATE THE TEST EQUIPMENT FOR 2-3 SECONDS AFTER RELEASING EITHER FOOT SWITCH. THE TRANSMITTER PCB ASSEMBLY WAS REPLACED, WHICH CORRECTED THE PROBLEM. AT THIS POINT IN TIME NO 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 REP THE FOOT SWITCH STICKS AND CONTINUES TO ACTIVATE THE SYSTEM. IT WAS DURING AN UNKNOWN PROCEDURE AND THERE WERE NO PATIENT CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK VAPR VIEW FOOTSWITCH ELECTROSURGICAL: CUTTING & COAGULATING GEI DEPUY MITEK NA 1102047

    Patients

    Seq Age Sex Outcome Treatment
    1