BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS, PK-SP GENERATOR

    MDR report key: 9970609 · Received April 16, 2020

    Report

    Report Number
    2951238-2020-00425
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Date of Event
    March 16, 2020
    Report Date
    June 24, 2020
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    PMA / PMN Number
    K031085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ADDITIONAL INFORMATION: H6, H10. CORRECTED DATA: H6 RESULT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE REPORTED PHENOMENON COULD NOT BE DUPLICATED. IT WAS NOTED DURING DEVICE EVALUATION THAT THE VENTILATION FAN WAS NOT FUNCTIONING. THIS MAY HAVE CONTRIBUTED TO THE REPORTED PHENOMENON ALLOWING THE RADIO-FREQUENCY (RF) BOARD TO OVERHEAT. FAILURE MAY ALSO BE ATTRIBUTED TO A FAULTY HAND PIECE, FOOT SWITCH OR OTHER ACCESSORY. NONE OF WHICH WERE NOT RETURNED TO OLYMPUS FOR EVALUATION. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE THROUGH REGULAR TRENDING ACTIVITIES AS DEFINED BY OLYMPUS SURGICAL TECHNOLOGIES AMERICA QUALITY MANAGEMENT SYSTEM PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND THE REPORTED FAILURE MODE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP), THERE WAS INTERMITTENT FIRING OF THE DEVICE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430273 GYRUS, PK-SP GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI GYRUS ACMI, INC 744000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR