BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM

    MDR report key: 16161702 · Received January 13, 2023

    Report

    Report Number
    3003790304-2023-00013
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    July 28, 2022
    Report Date
    May 12, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    UDI-DI
    00821925044111
    PMA / PMN Number
    K183647
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE WILL NOT BE RETURNED. AS CUSTOMER REPORTED TO OLYMPUS, IT WAS DETERMINED TO BE USER ERROR BY PEER REVIEW. THIS REPORT IS BEING SUBMITTED DUE TO THE ADDITIONAL INFORMATION RECEIVED THAT IS REFLECTED IN B5. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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. IT HAS BEEN OVER 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, ALTHOUGH THE DEVICE WAS NOT RETURNED FOR AN EVALUATION, THE ROOT CAUSE OF THIS FAILURE HAS BEEN DETERMINED TO BE DUE TO ENERGY DISTRIBUTION NEAR THE HIGHER END OF THE ACCEPTABLE RANGE OF ENERGY SETTINGS FOR AN EXTENDED PERIOD. THIS SUPPLEMENTAL REPORT INCLUDES INFORMATION ADDED TO D8 AND H4. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AND THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    OLYMPUS FURTHER RECEIVED INFORMATION THAT THE SERIAL NUMBER OF THE DEVICE IS MDUF210214. THE CORRECTIVE SURGERY WAS DETERMINED TO BE REPAIR WITH ILEAL INTERPOSITION. THE CUSTOMER CLARIFIED THAT THE THIRTY-NINE MINUTES REPORTED DURING THE SECOND LASER LITHOTRIPSY WAS DOCUMENTED AS TOTAL LASER TIME. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE PATIENT WAS DISCHARGED HOME WITH STABLE CONDITION.

    Description of Event or Problem · 0

    THE MEDWATCH (MW) 5113770 WAS RECEIVED BY OLYMPUS, WHICH REPORTED THAT THIS PATIENT UNDERWENT A SURGICAL LASER TREATMENT OF LEFT URETERAL STONES USING THIS SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM. THE PROVIDER USED THE DEVICE WITH 0.4 -1J ENERGY, FREQUENCY OF 16-40JZ, POWER OF 12.8-40W OVER NINE MINUTES AND FIFTY-TWO SECONDS FOR A TOTAL ENERGY OF 32.57 KJ. THE PATIENT UNDERWENT A SECOND LASER LITHOTRIPSY OF LEFT URETERAL STONE, USING THE SAME LASER DURING WHICH THE PROVIDER USED 1J ENERGY WITH 20HZ FREQUENCY, 20W POWER OVER THIRTY-NINE MINUTES FOR A TOTAL ENERGY OF 59.26KJ. THE PATIENT RETURNED THE THIRD TIME WITH THE SAME PROBLEM AND WAS DETERMINED TO HAVE A SEGMENT OF AVASCULARIZED NONVIABLE URETER. A CORRECTIVE SURGERY WAS DONE, AND PATIENT HAS DONE WELL SINCE. LACERATION, AS NOTED ON THE MW, WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528477 SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM GENERAL/MULTIPLE SURGICAL SOLID-STATE LASER SYSTEM GEX GYRUS ACMI, INC. TFL-PLS 00821925044111

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention