BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL 1010, 5 PK

    MDR report key: 9652857 · Received January 31, 2020

    Report

    Report Number
    2951238-2020-00328
    Event Type
    Injury
    Date Received
    January 31, 2020
    Report Date
    March 5, 2020
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    PMA / PMN Number
    K971450
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE DEVICE EVALUATION RESULTS. PLEASE THE UPDATES IN SECTIONS: D10, G4, G7, H2, H3, H6 AND H10. THE CUSTOMER RETURNED THREE UN-OPENED, SEALED 1010-2110-05 MODEL 1010 DEVICES WITH LOT NUMBER KR852332. THE DEVICES WERE OPENED AND INSPECTED. NO PHYSICAL ANOMALIES NOTED DURING INSPECTION. THE DEVICES WERE TESTED USING A GYRUS G1 TCRF GENERATOR AND BEEF TISSUE WITH A TARGET TEMPERATURE OF 85C AND TARGET ENERGY SET AT 500J. A SINGLE TESTING CYCLE WAS INITIATED FOR EACH DEVICE, THE PROBE HEATED TO THE TARGET TEMPERATURE AS INTENDED WITH NO ERROR CODE PRESENTED. TEMPERATURES REMAINED STABLE AND DID NOT SURPASS SET VALUES. SIMILAR RESULTS WERE OBSERVED WITH THE SECOND AND THIRD DEVICE. ALL THREE DEVICES FUNCTIONED AS DESIGNED. ONE FINAL TEST WAS COMPLETED WITH A SINGLE DEVICE. THE RAPID LESSION MODE WAS TRIGGERED FOR THE FINAL TEST. TEMPERATURE HELD STEADY AT 60C FOR THE DURATION OF THE CYCLE. TARGET ENERGY WAS REACHED AND NO ERROR CODES WERE PRESENTED. ATTEMPTS TO CONTACT THE CUSTOMER WERE UNSUCCESSFUL, DETAILS REGARDING THE GENERATOR OR SETTINGS ARE UNKNOWN. THE ROOT CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED. THE INVOLVED DEVICES WERE NOT RETURNED. TESTING OF DEVICES RETURNED BY THE CUSTOMER FROM THE SAME LOTS INVOLVED REVEALED NO ABNORMALITIES. DEVICES FUNCTIONED AS DESIGNED; TEMPERATURES REMAINED STABLE AND NO ERRORS WERE PRESENTED DURING TESTING. PER THE DEVICE IFU, 150-1319 REV DB, "WARNING: EXCESSIVE GENERATOR OUTPUT TIME OR GENERATOR OUTPUT LEVEL MAY RESULT IN BURNING TISSUE NOT INTENDED FOR COAGULATION." THE USER MUST REFER TO THE GENERATOR INSTRUCTIONS FOR USE TO DETERMINE APPROPRIATE TARGET TEMPERATURES AND TARGET ENERGY.

    Additional Manufacturer Narrative · 1

    AS PART OF OUR INVESTIGATION, THE SERVICE CENTER FOLLOWED UP WITH THE USER FACILITY FOR ADDITIONAL INCIDENT INFORMATION. WHILE THE SPECIFIC LOT NUMBER OF THE HAND PIECE IS UNKNOWN, IT WAS NARROWED DOWN TO KR852332 OR MK666385. THE DOCTOR IS NOT SURE WHICH LOT NUMBER DEVICE WAS USED IN THIS PROCEDURE. THE MODEL: 1010-2110-05 HAND PIECES USED IN THE CASE WILL NOT BE RETURNED FOR EVALUATION AS THE THEY WERE DISCARDED BY THE USER FACILITY AFTER THE PROCEDURE. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINE AT THIS TIME.

    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 IS 4 OF 4 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114032 MODEL 1010, 5 PK MODEL 1010, 5 PK GEI GYRUS ACMI, INC 1010-2110-05 MK666385

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MODEL 7035-3001/SN. (B)(6)