BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLTIVE PRO SUPERPULSED LASER SYSTEM

    MDR report key: 15327027 · Received August 31, 2022

    Report

    Report Number
    3003790304-2022-00189
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Report Date
    December 6, 2022
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    UDI-DI
    00821925044135
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED 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, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE BURNING FIBER COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, AT THE BEGINNING OF A THERAPEUTIC ENDOLUMINAL URETERO-LITHECTOMY, THE PLASTIC CONNECTOR AT THE FIBER STARTED BURNING AND PRODUCED A FLAME WHICH 'STOOD STRAIGHT OUT ABOUT FIVE (5) CM FROM THE FIBER'S PLASTIC SLEEVE. THE FLAME WAS EXTINGUISHED WITH PAPER TOWELS (CLOSED AROUND THE FLAME). THE PROCEDURE HAD AN UNSPECIFIED DELAY WHILE THE STAFF REALIZED WHAT WAS GOING ON. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE GENERATOR DID NOT SHUT DOWN DURING THE FIRE AND THE STAFF DID NOT RESTART IT EITHER. THERE WAS NO PATIENT OR USER HARM. THIS EVENT INCLUDES 2 REPORTS: (B)(6): TFL-SLS, SERIAL (B)(4). (B)(6): TFL-FBX200S, LOT KR212626. THIS REPORT IS 1 OF 2 FOR (B)(6): TFL-SLS, SERIAL (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069470 SOLTIVE PRO SUPERPULSED LASER SYSTEM GENERAL/MULTIPLE SURGICAL SOLID-STATE LASER SYSTEM GEX GYRUS ACMI, INC. TFL-SLS 00821925044135

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TFL-FBX200S LOT: KR212626