BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR 3.5MM SUCTION ELECTRODE

    MDR report key: 1190653 · Received October 6, 2008

    Report

    Report Number
    1221934-2008-00472
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 1, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME, AWAITING THE RECEIPT OF THE COMPLAINT DEVICE TOWARDS CONDUCTING A ROOT CAUSE ANALYSIS, THE RESULTS OF WHICH WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE, 3 TIMES THE PATIENT APPEARED TO BE SHOCKED WHILE THE VAPR ELECTRODE WAS BEING ACTIVATED. ON THE 3RD TIME, THERE WAS SOME SOFT TISSUE BURNING WITHIN THE SUBACROMIAL SPACE, THE SURGEON DID NOT CONSIDER THE DEGREE OF BURN TO BE AN ISSUE, PATIENT NOT ADVERSELY AFFECTED. ALSO, THERE WAS THE STRONG ODOR OF SMOKE IN THE ROOM, STRONG ENOUGH SO, THAT THEY THOUGHT THAT THERE MAY BE A FIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPR 3.5MM SUCTION ELECTRODE ELECTROSURGICAL, CUTTING AND COAGULATING GEI DEPUY MITEK 225350 0803060

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK