BEUDAMED
    FDA Recall Terminated

    Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery

    Recall: Z-2294-2021 · Initiated June 30, 2021

    Recall

    Recall Number
    Z-2294-2021
    Event Number
    88229
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 30, 2021
    Terminated
    January 26, 2024
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    Description

    Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery

    Reason

    Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets

    Action

    Olympus issued Urgent Medical Device Correction on June 30, 2021 via Federal Express Second Day Delivery. Letter states reason for recall, health risk and action to take: To mitigate and prevent thermal injury events, Olympus is issuing a software upgrade for the Soltive Laser to version 2.1. Software version 2.1 includes a new Ureteral Stone Preset of 8W under the Lithotripsy treatment mode. The Soltive Laser Instructions for Use (IFU) has been updated to reflect these software changes which also includes a pop-up alert reminding user to consider the potential clinical consequences of selecting settings greater than 20W in sensitive anatomy like the ureter. Enclosed with this letter is an addendum to the IFU containing a summary of the new updated IFU sections. Action Steps: 1. Starting June 2021 an Olympus representative will reach out to you to arrange a mutually convenient time to have your product(s) updated. 2. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0XXX and provide your contact information as indicated in the portal. 3. If you have distributed these devices outside your facility, please notify your customers of this corrective action immediately. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Olympus regrets any inconvenience from this corrective action and fully appreciates your prompt cooperation in addressing this situation. Please do not hesitate to contact me directly at at [email protected] for any additional information concerning this matter.

    Distribution

    US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore

    Quantity

    408 units