BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITRON 4.0 DUAL RF S5

    MDR report key: 2563269 · Received May 3, 2012

    Report

    Report Number
    2428235-2012-00007
    Event Type
    Injury
    Date Received
    May 3, 2012
    Date of Event
    March 1, 2012
    Report Date
    April 3, 2012
    Manufacturer
    ELLMAN INT'L INC.
    Product Code
    GEI
    PMA / PMN Number
    K082834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR WAS MADE AWARE OF THE ADVERSE PT REACTION THAT TOOK PLACE IN (B)(6) BY WAY OF (B)(6) FORWARDING A COPY OF A REPORT THE DISTRIBUTOR FILED WITH (B)(6). THE DISTRIBUTOR DID NOT PROVIDE ANY OTHER INFO OTHER THAN THIS EVENT OCCURRED DURING A TURBINATE PROCEDURE. MULTIPLE ATTEMPTS TO OBTAIN ADD'L INFO CONCERNING THE EVENT WERE MADE. RETURN OF THE DEVICE WAS ALSO REQUESTED. NO INFO HAS BEEN FORTHCOMING. NOTHING IN THE COMPLAINT SUGGESTS THAT A MALFUNCTION OF THE ELLMAN GENERATOR CAUSED THE OBSTRUCTION. WE WILL UPDATE THIS REPORT AS WE BECOME AWARE OF MORE INFO CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE MFR WAS MADE AWARE OF AN ADVERSE PT REACTION TO A PROCEDURE THAT TOOK PLACE AT (B)(6), BY WAY OF (B)(6). WE WERE INFORMED THE SURGITRON 4.0 DUAL RF S5 GENERATOR WAS USED FOR A TURBINATE PROCEDURE. WE WERE TOLD THAT THE GENERATOR WAS USED ON TWO PATIENTS AND THAT THERE WAS A NASAL OBSTRUCTION. THE PROCEDURE WAS STOPPED AND THERE WAS SURGICAL INTERVENTION TO UNCLOG THE NOSE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITRON 4.0 DUAL RF S5 GEI ELLMAN INT'L INC. IEC5-S30

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention