BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYRUS ENT G3 WORKSTATION

    MDR report key: 9652671 · Received January 31, 2020

    Report

    Report Number
    2951238-2020-00327
    Event Type
    Injury
    Date Received
    January 31, 2020
    Report Date
    June 23, 2020
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    PMA / PMN Number
    K041285
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINE THE CAUSE OF THE REPORTED COMPLAINT SINCE THE CUSTOMER¿S INSTRUMENTS WERE NOT RETURNED FOR EVALUATION. A SERVICE HISTORY RECORD REVIEW SHOWS THAT THIS DEVICE WAS ESTIMATED AND REPAIRED ACCORDINGLY AND THERE WERE NO ABNORMALITIES NOTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE DEVICE EVALUATION RESULTS. A GYRUS ENT G3 GENERATOR REF. 7035-3001, SERIAL# (B)(6), EQUIPPED WITH PLASMABLEND VERION 1.12 AND TCRF S/W VERSION 2.12, WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION FOUND NO VISUAL DAMAGE ON THE FRONT SOCKETS. ALL SWITCHES ARE FUNCTIONAL. NOTED THAT THERE ARE ERRORS 14 AND 412¿FOOT PEDAL STUCK CAPTURED IN ERROR LOG HISTORY LIKELY DUE TO USER ERROR. THE GENERATOR¿S MONOPOLAR TCRF SIDE WAS CHECKED AND RECOGNIZED OUR TEST SOMNOPLASTY SINGLE NEEDLE ELECTRODE REF. 1010-2110-05. OBSERVED THAT THE GENERATOR COULD GENERATE SUFFICIENT RF POWER TO COAGULATE A PIECE TISSUE SAMPLE, NO OVERHEATING OR CHARRING ON THE TISSUE, AND TEMPERATURE REMAINED WITHIN ITS TARGET SETTING. NOTED THAT THERE WAS AN AUDIBLE BEEP AS EVERY 50J HAD DELIVERED DURING COAGULATION WHICH IS NORMAL. IN ADDITION, THE BIPOLAR PC AND PK SOCKETS WERE ALSO CHECKED AND PASSED FUNCTIONAL INSPECTION. NO ERROR OCCURRED DURING ACTIVATION. FURTHER EVALUATION, A FULL INSPECTION WAS PERFORMED IN ELECTRONICS SERVICE LINE. THE DEVICE PASSED ALL THE MEASURABLE POWER OUTPUTS INSPECTION, AND NO PROBLEM OCCURRED DURING BURN-IN TEST. BASED ON EVALUATION FINDINGS, THE DEVICE WAS FUNCTIONAL AND PASSED THE INSPECTION. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINE, SINCE THE CUSTOMER¿S INSTRUMENTS WERE NOT RETURNED FOR EVALUATION. THE DEVICE WAS MANUFACTURED ON JULY 2006. THE INSTRUCTION MANUAL STATES ¿THE ELECTRODE TIPS SHOULD NOT BE REMOVED DURING RF ON MODE AS RF IS BEING DELIVERED CONSTANTLY. SUPERFICIAL SKIN BURNS COULD OCCUR.¿ FURTHERMORE, THE INSTRUCTION MANUAL PROVIDES THE FOLLOWING WARNINGS: WARNING: EXCESSIVE GENERATOR OUTPUT TIME OR GENERATOR OUTPUT LEVEL MAY RESULT IN BURNING TISSUE NOT INTENDED FOR COAGULATION. WARNING: DO NOT TOUCH THE DEVICE TIP WHILE THE DEVICE IS ACTIVATED. THIS MAY CAUSE INJURY. THE DEVICE TIP MAY REMAIN HOT ENOUGH TO CAUSE BURNS AFTER ELECTROSURGICAL CURRENT IS DEACTIVATED. WARNING: ENSURE THAT THE NON-INSULATED PORTION OF THE ELECTRODE REMAINS COMPLETELY INSERTED INTO THE TISSUE DURING COAGULATION. FAILURE TO DO SO MAY CAUSE DAMAGE TO THE MUCOSA. WARNING: ENSURE THAT THE ELECTRODE REMAINS COMPLETELY EXTENDED FROM THE GUIDE SLEEVE DURING USE. FAILURE TO DO SO MAY CAUSE HEATING OF THE METAL GUIDE SLEEVE, WHICH COULD DAMAGE TISSUE THAT IS IN CONTACT WITH THE SLEEVE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE FOLLOWING DEVICE EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED. HAND PIECES USED IN THE PROCEDURE ARE MODEL 1010-2110-05 WITH LOT NUMBERS KR852332 OR MK666385.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED THAT A PATIENT SUSTAINED FULL THICKNESS BURNS AT THE BASE OF THE TONGUE DURING UVULOPALATOPHARYNGOPLASTY (UPPP) PROCEDURES USING A SOMNOPLASTY MACHINE AND SOFT PALATE HAND PIECES. THE DOCTOR REPORTED THAT THE PATIENT¿S SOFT PALATE CASE WAS PERFORMED TWO MONTHS AGO. THE INJURY WAS DISCOVERED ONE WEEK POSTOPERATIVE DURING A FOLLOW UP VISIT. IT WAS REPORTED THAT THE PATIENT WAS IN THEIR IN 20¿S WITH A HEAVY BUILD. THE NON-INSULATED PORTION OF THE ELECTRODE WAS COMPLETELY INSERTED INTO THE TISSUE DURING COAGULATION. THE ELECTRODE COMPLETELY EXTENDED FROM THE GUIDE SLEEVE DURING USE. THERE WERE NO ABNORMALITIES NOTED WITH THE ELECTRODES DURING USE. THERE WERE NO ALARMS/ALERTS NOTED ON THE GENERATOR DURING ACTIVATION. THE USER WAS TRAINED AND EXPERIENCED WITH THE EQUIPMENT. THE PATIENT¿S BURNS WERE TREATED WITH ANTIBIOTICS. THIS 3 OF 4 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116268 GYRUS ENT G3 WORKSTATION GYRUS ENT G3 WORKSTATION GEI GYRUS ACMI, INC 7035-3001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention