BEUDAMED
    FDA Adverse Event Death Summary report: N

    GYRUS ENT G3 WORKSTATION

    MDR report key: 4142520 · Received September 23, 2014

    Report

    Report Number
    2951238-2014-00436
    Event Type
    Death
    Date Received
    September 23, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 10, 2014
    Manufacturer
    GYRYS ACMI INC.
    Product Code
    GEI
    PMA / PMN Number
    K080844
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE PT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. REVIEW OF THE INSTRUMENT HISTORY SHOWED THE DEVICE WAS LAST SERVICED ON (B)(4) 2012 AND THE DEVICE HAS NOT BEEN SERVICED SINCE THEN. IF ADD'L INFO BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT ONE WEEK AFTER UNDERGOING A TONSILLECTOMY PROCEDURE, THE PT EXPIRED DUE TO A RE-BLEED. DURING THE PROCEDURE, THE PHYSICIAN USED THE GENERATOR WITH A UNIVERSAL PLASMA KNIFE REUSABLE HANDPIECE AND PLASMACISION DISPOSABLE TIP. THE USER FACILITY STATED THERE WAS NO INTER-OPERATIVE ISSUES WITH THE OLYMPUS DEVICES DURING THE PROCEDURE AND THE EQUIPMENT FUNCTIONED NORMALLY. THE GENERATOR HAS BEEN REMOVED FROM SERVICE. OLYMPUS FOLLOWED UP WITH TO OBTAIN ADD'L INFO REGARDING THE REPORTED EVENT, BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591131 GYRUS ENT G3 WORKSTATION WORKSTATION GEI GYRYS ACMI INC. 7035-3001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PLASMACISION DISPOSABLE TIP, SERIAL #: UNK| UNIVERSAL PLASMA KNIFE HANDPIECE, SERIAL #: UNK