BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIBEL FULGURATING ELECTRODE BALL TIP

    MDR report key: 2993869 · Received March 1, 2013

    Report

    Report Number
    1519132-2013-00009
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 1, 2013
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FAS
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSP HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE PROXIMAL CONNECTION, AT BUGBEE ELECTRODE, BURNED APART DURING A SURGICAL PROCEDURE. PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PT. THIS IS DEVICE ONE OF TWO. (SEE 1519132-2013-00008 FOR THE SECOND DEVICE.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89395 FLEXIBEL FULGURATING ELECTRODE BALL TIP FLEXIBLE FULGURATING ELECTRODE BALL TIP FAS GYRUS ACMI, INC. 257F8

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK