BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM

    MDR report key: 15780110 · Received November 11, 2022

    Report

    Report Number
    3003790304-2022-00293
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Date of Event
    July 12, 2022
    Report Date
    December 20, 2022
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    UDI-DI
    00821925044111
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INSPECTION AND TESTING, SERVICE FOUND THE EMERGENCY OFF (EMO) BUTTON WAS LOOSE. THE CUSTOMER REQUESTED THE DEVICE BE RETURNED TO THE FACILITY WITHOUT BEING REPAIRED. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE OF THE LOOSE EMERGENCY OFF BUTTON (EMO) IS LIKELY NORMAL WEAR AND TEAR. THE EMO BUTTON DESIGN CHANGED IN AUGUST 2022 AFTER THE DEVICE WAS MANUFACTURED IN 2019. THE DESIGN CHANGE DID NOT AFFECT ITS FUNCTIONALITY. THE DESIGN WAS CHANGED BY NOW HAVING THE USER ONLY PUSH THE EMO BUTTON RATHER THAN ROTATING THE KNOB CLOCKWISE UNTIL IT IS RELEASED INTO THE ORIGINAL POSITION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE SUBJECT DEVICE WAS SENT TO AN OLYMPUS SERVICE CENTER FOR PREVENTIVE MAINTENANCE. DURING INSPECTION AND TESTING, SERVICE FOUND THE EMERGENCY OFF (EMO) BUTTON WAS LOOSE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911758 SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM GENERAL/MULTIPLE SURGICAL SOLID-STATE LASER SYSTEM GEX GYRUS ACMI, INC. TFL-PLS 00821925044111

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown