BEUDAMED
    FDA Adverse Event Other Summary report: N

    33CM PKS NEEDLE ELECTRODE

    MDR report key: 1694432 · Received May 11, 2010

    Report

    Report Number
    2183680-2010-00020
    Event Type
    Other
    Date Received
    May 11, 2010
    Date of Event
    April 12, 2010
    Report Date
    May 11, 2010
    Manufacturer
    GYRUS MEDICAL INC
    Product Code
    GEI
    PMA / PMN Number
    K031079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED WITH NO ABNORMALITIES NOTED. THE DEVICE WAS SET TO THE CORRECT GENERATOR DEFAULTS AND PERFORMED AS DESIGNED. ANALYSIS OF THE DEVICE FOUND NO PROBLEMS. DEVICE OPERATES ACCORDING TO THE IFU AND MFR SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING A PROCEDURE AT (B)(6), THE PT SUFFERED A MILD BURN ON THEIR FINGER. OUR PLASMA NEEDLE DEVICE AND THE G400 GENERATOR WAS BEING USED DURING THE PROCEDURE ALONG WITH OTHER ELECTRICAL SURGICAL INSTRUMENTS. IT IS SUSPECTED THAT MONOPOLAR ENERGY LEAKAGE VIA A "MEGADYNE" UNIPOLAR PT RETURN PAD CAUSED THE BURN WHEN THE NEEDLE WAS ACTIVATED. THE PT'S ARMS WERE POSITIONED BY THE PT'S SIDES AND MAY HAVE BEEN EXPOSED OR OFF THE PAD WHEN THE INJURY OCCURRED. THE BURN WAS TREATED WITH TOPICAL CREAM, AND NO OTHER INCIDENTS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 33CM PKS NEEDLE ELECTRODE PKS NEEDLE ELECTRODE, 33CM GEI GYRUS MEDICAL INC 915000PK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1