BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM

    MDR report key: 16499959 · Received March 7, 2023

    Report

    Report Number
    3003790304-2023-00109
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Report Date
    July 24, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    UDI-DI
    00821925044111
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE (LASER SYSTEM) WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE IS UNKNOWN AT THIS TIME. ACCORDING TO THE REPORT PROVIDED, THERE WAS AN ERROR MESSAGE OBSERVED. PER THE REPORT, THE ERROR MESSAGE INDICATED A DAMAGED BLAST SHIELD. WHEN INSPECTED, THE BLAST SHIELD WAS FOUND DAMAGED WITH VISIBLE SIGNS OF SMOKE ON THE WINDOW. ACCORDING TO THE REPORT, THE BLAST SHIELD WAS REPLACED. FOLLOW UP IS IN PROGRESS. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE E1 "TELEPHONE NUMBER" WAS CORRECTED DUE TO INCORRECT COUNTRY CODE FORMAT. THE E2 AND G2 FIELDS WERE CORRECTED BASED ON THE INFORMATION AVAILABLE AT THE INITIAL REPORT SUBMISSION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 2 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEFINITIVE ROOT CAUSE OF SMOKING AT THE FIBER CONNECTOR INTERFACE COULD NOT BE DETERMINED AS THERE WAS NO DEVICE RETURNED FOR A PHYSICAL EVALUATION. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATES: "ANY TAMPERING WITH THE LASER FIBER CONTACT CONNECTOR MAY CAUSE UNWANTED EMISSION OF LASER RADIATION. BEFORE PERFORMING ANY LASER EMISSION, MAKE SURE THAT THE PROBE IS INSERTED CORRECTLY. PAY ATTENTION TO THE FIRING DIRECTION." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONCE LASER WAS STARTED "(IE READY MODE") THE LASER STARTED TO SMOKE AT THE ENTRY POINT WHERE THE LASER FIBER IS INSERTED INTO THE MACHINE. LASER WAS IMMEDIATELY STOPPED BY THE RESIDENT AND WAS TAKEN OUT OF THE ROOM. THE ISSUE FOUND DURING AN UNSPECIFIED PROCEDURE. ACCORDING TO THE REPORT, THE BIOMED WAS CONTACTED; THE LASER AND FIBER WERE RETRIEVED FROM THE OPERATING ROOM (OR) ROOM. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT INCLUDES TWO (2) REPORTS TO CAPTURE THE LASER FIBER AND LASER CONSOLE REPORTED ON THE EVENT. REPORT WITH PATIENT IDENTIFIER (B)(6) (TFL-FBX200S, LOT KR222964 200 MICRON TFL SINGLE USE FIBER). REPORT WITH PATIENT IDENTIFIER (B)(6) (TFL-PLS, SERIAL (B)(4) LASER SYSTEM CONSOLE). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (TFL-PLS, SERIAL (B)(4)LASER SYSTEM CONSOLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790988 SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM SUPERPULSED LASER SYSTEM GEX GYRUS ACMI, INC. TFL-PLS 00821925044111

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TFL-FBX200S. LOT KR222964.