BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS, PK-SP GENERATOR

    MDR report key: 11860249 · Received May 20, 2021

    Report

    Report Number
    3003790304-2021-00093
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 15, 2021
    Report Date
    June 16, 2021
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    UDI-DI
    00821925009271
    PMA / PMN Number
    K031085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. THE FOLLOWING SECTIONS WERE UPDATED: G3, G6, H2, H4, H6, AND H10. A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED AS THIS DEVICE HAS BEEN SERVICED BEFORE. A REVIEW OF THE SERVICE HISTORY RECORD REVIEW SHOWS NO ABNORMALITIES. THE CUSTOMER REPORTED THAT THEIR PK-SP GENERATOR IS NOT GETTING HOT ENOUGH. THIS WAS NOTED TO BE FROM THE CUSTOMER WHEN TESTING THE GENERATOR. NOT MUCH MORE INFORMATION WAS PROVIDED BY THE CUSTOMER AND MULTIPLE ATTEMPTS TO GATHER MORE INFORMATION WAS UNSUCCESSFUL. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR FURTHER EVALUATION. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    DURING A CALL WITH TAC (TECHNICAL ASSISTANCE CENTER) SUPPORT ENGINEER IT WAS DETERMINED THAT THE CUSTOMER IS TESTING THE OUTPUT OF THE DEVICE AND WANTED TO KNOW IF THERE IS A TOLERANCE/RANGE TO THE READING ON THE FLUKE TEST EQUIPMENT FOR OUTPUT READING. TAC ADVISED THE CUSTOMER TO LOCATE THE BIOMEDICAL MANUAL AND ONCE LOCATED, CUSTOMER WAS ADVISED TO REFERENCE THE BIOMEDICAL MANUAL AS THERE IS A OUTPUT RANGE LIMIT FOR EACH OF THE OUTPUT TEST. TO DATE THERE ARE NO OTHER ISSUES REPORTED. IT IS LIKELY THAT THE REPORTED ISSUE WAS RESOLVED AS CUSTOMER DID NOT CALL BACK FOR ADDITIONAL INFORMATION. BASED ON TAC CONVERSATION WITH THE CUSTOMER THE PROBABLE CAUSE OF THE ISSUE COULD BE DUE TO USE HANDLING AND OR TRAINING ISSUE. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATIONS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DEVICE IS NOT GETTING HOT ENOUGH. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749916 GYRUS, PK-SP GENERATOR GYRUS, PK-SP GENERATOR GEI GYRUS ACMI, INC 744000 00821925009271

    Patients

    Seq Age Sex Outcome Treatment
    1