BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLTIVE PRO SUPERPULSED LASER SYSTEM

    MDR report key: 9957007 · Received April 14, 2020

    Report

    Report Number
    2951238-2020-00416
    Event Type
    Injury
    Date Received
    April 14, 2020
    Date of Event
    March 24, 2020
    Report Date
    June 24, 2020
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEX
    PMA / PMN Number
    K183647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ADDITIONAL INFORMATION: H6, H10. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE ROOT CAUSE OF THE REPORTED FAILURE CAN LIKELY BE ATTRIBUTED TO USER ERROR AS NO FUNCTIONAL PROBLEMS OR SAFETY RISKS WERE IDENTIFIED DURING ESTIMATION AND THE MANUFACTURER INDICATES THE DEVICE WAS BUILT TO SPECIFICATION. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE THROUGH REGULAR TRENDING ACTIVITIES AS DEFINED BY OLYMPUS SURGICAL TECHNOLOGIES AMERICA QUALITY MANAGEMENT SYSTEM PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THERE WAS NO PRODUCT PROBLEM REPORTED. THE CAUSE OF THE EVENT WAS LIKELY DUE TO USE OF THE DEVICE.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A REPORT FROM A USER FACILITY STATING THAT DURING A URETEROSCOPY WITH LITHOTRIPSY PROCEDURE, THE LASER BREACHED THE WALL OF THE PATIENT'S URETER. THE URETERAL INJURY WAS NOTED JUST AFTER THE INITIAL ACTIVATION OF THE LASER. THE CUSTOMER REPORTED THAT THE DEVICE HAD 0.2 PULSE ENERGIES AND 30 HERTZ FREQUENCY ON THE LEFT PEDAL AND 16 WATTS FRAGMENTING SETTING ON THE RIGHT PEDAL. THE DOCTOR HAD ACCIDENTALLY HIT THE RIGHT PEDAL AT SOME POINT DURING THE PROCEDURE BUT SHE DOES NOT KNOW IF THAT IS WHEN THE BREACH OF THE WALL OCCURRED. A URETERAL STENT WAS TEMPORARILY PLACED FOR 6 WEEKS TO ASSIST IN THE HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424055 SOLTIVE PRO SUPERPULSED LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX GYRUS ACMI, INC TFL-SLS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention