BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKS SEAL,OPEN FCP 9-PIN,CURVE (5/PK)

    MDR report key: 8727469 · Received June 24, 2019

    Report

    Report Number
    2951238-2019-00969
    Event Type
    Injury
    Date Received
    June 24, 2019
    Report Date
    September 11, 2019
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    PMA / PMN Number
    K024286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE ADDITIONAL INFORMATION. PLEASE THE UPDATES IN SECTIONS: H2, H3, H6 AND H10. THE CUSTOMER REPORTED THAT TWO LOT NUMBERS WERE USED DURING THE THREE REPORTED CASES, MK703384 AND KR824896. THE ASSOCIATED PACKAGE-LEVEL (P7400501-001 MK703384 KR824896) AND DEVICE-LEVEL (P6000146-001 MK703382 MK785323 MK790744 KR818013) DHRS CORRESPONDING TO THESE TWO LOT NUMBERS HAVE BEEN REVIEWED. ALL RECORDS INDICATE THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. SINCE THE CUSTOMER DISCARDED THEIR DEVICE A SAMPLE DEVICE WAS TESTED FOR HEAT RETENTION NEAR THE DISTAL END. TESTING WAS CARRIED OUT UNDER A VENTILATED HOOD WITH A COMPATIBLE GENERATOR AT DEFAULT SETTINGS, VP2 AND 60 WATTS. DURING TESTING IT WAS NOTED THAT THE DISTAL END REMAINED HOT, AND MAY BE CAPABLE OF BURNING EXPOSED TISSUE AFTER DEACTIVATING THE DEVICE. DURING TESTING THE DEVICE WAS ACTIVATED FOR 2 CONTINUOUS MINUTES AND THE TEMPERATURE NEAR THE DISTAL END WAS RECORDED USING A FLUKE 63 IR THERMOMETER. AFTER 120 SECONDS OF CONTINUOUS ACTIVATION AT DEFAULT SETTINGS, THE PLASTIC MOLDING SURROUNDING THE TOP JAW REACHED A TEMPERATURE OF 155 DEGREES FAHRENHEIT. TEMPERATURE SIGNIFICANTLY DECREASED PROXIMALLY WITH THE HINGE REACHING TEMPERATURES LESS THAN 80 DEGREES FAHRENHEIT. THE THUMB LOOPS REMAINED AT ROOM TEMPERATURE DURING THE DURATION OF TESTING. FOLLOWING 120 SECONDS OF CONTINUOUS ACTIVATION, COAGULATION WAS DISCONTINUED. AFTER 30 SECONDS OF REST, THE PLASTIC MOLDING SURROUNDING THE TOP JAW REGISTERED APPROXIMATELY 90 DEGREES FAHRENHEIT AND COOLED TO ROOM TEMPERATURE FOLLOWING 120 SECONDS OF REST. IT IS IMPORTANT TO NOTE THAT HEAT RETENTION WILL VARY DEPENDENT ON ACTIVATION TIME AND GENERATOR SETTINGS USED. THE DEVICE IFU, 910117-001 REV HD, GIVES THE FOLLOWING WARNINGS; "WARNING: EXCESSIVE GENERATOR OUTPUT TIME OR GENERATOR OUTPUT LEVEL MAY RESULT IN BURNING TISSUE NOT INTENDED FOR COAGULATION", AND, "WARNING: THE DEVICE TIP MAY REMAIN HOT ENOUGH TO CAUSE BURNS AFTER ELECTROSURGICAL CURRENT IS DEACTIVATED." THE CUSTOMER REPORT THAT THE PATIENT WAS BURNED WITH "...WHAT THEY BELIEVE [WAS], THE SHAFT OF THE INSTRUMENT" COULD NOT BE CONFIRMED AS THE DEVICES INVOLVED WERE DISCARDED BY THE CUSTOMER AND NOT RETURNED TO OLYMPUS FOR EVALUATION. TESTING OF A SIMILAR DEVICE SHOWED THAT THE DISTAL END OF THE DEVICE REMAINS HOT TO THE TOUCH AND MAY BE CAPABLE OF EXPOSED TISSUE AFTER PROLONGED ACTIVATION. THE DEVICE IFU, 910117-001 REV HD, GIVES THE FOLLOWING WARNINGS; "WARNING: EXCESSIVE GENERATOR OUTPUT TIME OR GENERATOR OUTPUT LEVEL MAY RESULT IN BURNING TISSUE NOT INTENDED FOR COAGULATION", AND, "WARNING: THE DEVICE TIP MAY REMAIN HOT ENOUGH TO CAUSE BURNS AFTER ELECTROSURGICAL CURRENT IS DEACTIVATED."

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE SERVICE CENTER FOR EVALUATION AS IT WAS DISCARDED BY THE USER FACILITY AFTER THE PROCEDURE. THE USER FACILITY WAS UNABLE TO DETERMINE IF LOT NUMBER MK703384 OR KR824896 WAS USED IN THIS PROCEDURE. THIS REPORT IS TO ACCOUNT FOR PATIENT 3 OF 3.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT DURING A POST-OP VISIT A THERMAL BURN WAS NOTED ON THE PATIENT¿S VULVA. THE PATIENT HAD PREVIOUSLY UNDERGONE A THERAPEUTIC VAGINAL HYSTERECTOMY PROCEDURE. THE DOCTOR REPORTED THAT SUCTION WAS USED TO REMOVE STEAM. THERE WERE NO ANOMALIES NOTED WITH THE DEVICE DURING USE; HOWEVER, DUE TO THE TYPE OF INJURY IT IS BELIEVED THAT THERMAL HEAT WAS BEING TRANSFERRED FROM THE SHAFT OF THE DEVICE TO THE PATIENT¿S TISSUE. THE DEVICE WAS FROM ONE OF TWO DIFFERENT LOTS AND THE USER FACILITY IS UNABLE TO DETERMINE WHICH LOT WAS USED. THE INTENDED PROCEDURE WAS NOT PROLONGED AND WAS COMPLETED WITH THE SAME DEVICE. THE PATIENT¿S BURN WAS TREATED WITH SILVADENE OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522625 PKS SEAL,OPEN FCP 9-PIN,CURVE (5/PK) PKS SEAL,OPEN FCP 9-PIN GEI GYRUS ACMI, INC 915000PK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other