BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM

    MDR report key: 17235632 · Received June 30, 2023

    Report

    Report Number
    3003790304-2023-00255
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    May 30, 2023
    Report Date
    September 8, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    UDI-DI
    00821925044111
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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. 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 ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "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.

    Additional Manufacturer Narrative · 0

    FOLLOW UP COMMUNICATION WITH THE CUSTOMER REPORTED THAT THE SAME DEVICE (DIFFERENT) FIBER WAS USED TO COMPLETE THE PROCEDURE. CUSTOMER DID NOT PROVIDE INFORMATION REGARDING THE TYPE OF PROCEDURE PERFORMED. THE REPORTED EVENT DID NOT AFFECT THE OUTCOME OF PROCEDURE , CUSTOMER STATED " ONLY SLOWED THE CASE DOWN ". NO INTERVENTION WAS PERFORMED. THE SUBJECT DEVICE (LASER UNIT ) WAS NOT RETURNED FOR EVALUATION. AN OLYMPUS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ONSITE AND PERFORMED AN ONSITE INSPECTION. FSE PERFORMED INSPECTION AND FOUND NO ISSUES WITH THE DEVICE. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION. PLEASE SEE H10 FOR DETAILS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LASER FIBER CAUGHT ON FIRE DURING A THERAPEUTIC AN UNSPECIFIED PROCEDURE AT THE CONNECTOR END. THE FIBER WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO ERRORS REPORTED. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT INCLUDES TWO REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (LASER FIBER TFL-FBX150BS LOT KR111723). REPORT WITH PATIENT IDENTIFIER (B)(6) (LASER SYSTEM TFL-PLS SN: (B)(6). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (LASER SYSTEM TFL-PLS SN: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278676 SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX GYRUS ACMI, INC. TFL-PLS 00821925044111

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown LASER FIBER TFL-FBX150BS LOT KR111723