BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM

    MDR report key: 16383695 · Received February 15, 2023

    Report

    Report Number
    3003790304-2023-00077
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    January 19, 2023
    Report Date
    May 31, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    UDI-DI
    00821925044111
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO E2. 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, IT IS LIKELY THAT THE DEFINITIVE ROOT CAUSE OF THE FIBER CATCHING FIRE UPON CONNECTING CAN BE ATTRIBUTED TO THE OPTICAL POWER OUT OF SPECIFICATION. THE EVENT WAS CONFIRMED THROUGH FUNCTIONAL TESTS WITH A SERVICE FIBER DURING HIGH POWER MODE. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "THE SOLTIVE LASER SYSTEM IS DESIGNED FOR MAXIMUM SAFETY AND PERFORMANCE. UNDER NORMAL OPERATING CONDITIONS AND CAREFUL USE, THE MANUFACTURER RECOMMENDS A CHECK-UP OF THE DEVICE BY A QUALIFIED TECHNICIAN, EVERY 12 MONTHS. THE INTENSIVE USE, DUST, OR CONTINUOUS MOVEMENT OF THE LASER IN DIFFERENT PLACES MAY REQUIRE MORE FREQUENT MONITORING." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    FIELD SERVICE ENGINEER (FSE) WENT ONSITE (CUSTOMERS FACILITY) AND INSPECTED THE DEVICE. FSE PERFORMED THE DEVICE EVALUATION AND INSPECTION. "INSPECTION VERIFYING OPTICAL POWER" SECTION TEST WAS PERFORMED AND FOUND THERE WAS A SPARK AT THE DISTAL END OF THE SERVICE LASER FIBER ON HIGH POWER. FSE DETERMINED THE HIGH POWER VALUE FAILED, DUE TO IT WAS OUT OF SPECIFICATIONS. BASED ON FSE INSPECTION FINDINGS, THE DEVICE ¿FAILED TEST ON HIGH POWER VALUE DUE TO LOW OUTPUT AND SPARKS SEEN AT DISTAL END OF THE SERVICE FIBER. THE DEVICE IS BEING SHIPPED BACK TO OLYMPUS FOR FURTHER INVESTIGATION. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE AND OR RECEIVED. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    COMPANY REPRESENTATIVE (SALES REP.) CALLED IN TO REPORT THAT THE USER REPORTED A THERMAL EVENT. THERE WAS SPARKS GENERATED WHEN THE USER INSERTED THE FIBER TO THE SOLTIVE GENERATOR. THE REPORTED ISSUE OCCURRED DURING A DIAGNOSTIC (UNSPECIFIED PROCEDURE). IN A FOLLOW UP COMMUNICATION WITH THE CUSTOMER, IT WAS STATED THE ISSUE OCCURRED WHEN THE DOCTOR PLUGGED THE FIBER IN AND THE FIBER SPARKED AND HAD A FLAME AT THE CONSOLE. CUSTOMER STATED, THIS WAS DURING A PROCEDURE BUT DID NOT TOUCH THE PATIENT. NO FURTHER DETAILS WERE PROVIDED. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED. THIS EVENT INCLUDES TWO REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) TFL-PLS SN: (B)(4) LASER SYSTEM SOLTIVE GENERATOR. REPORT WITH PATIENT IDENTIFIER (B)(6) TFL-FBX200S LOT KR233094 LASER FIBER. THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) TFL-PLS SN: (B)(4) LASER SYSTEM SOLTIVE GENERATOR

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656815 SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM LASER SYSTEM GEX GYRUS ACMI, INC. TFL-PLS 00821925044111

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TFL-FBX200S LOT KR233094 LASER FIBER