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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus

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  Class 2 Device Recall Olympus see related information
Date Initiated by Firm June 30, 2021
Create Date August 15, 2021
Recall Status1 Terminated 3 on January 26, 2024
Recall Number Z-2294-2021
Recall Event ID 88229
510(K)Number K211401  
Product Classification Powered laser surgical instrument - Product Code GEX
Product 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
Code Information Software Version 2.0 (all serial numbers)
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
For Additional Information Contact SAME
484-896-5000
Manufacturer Reason
for Recall		 Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
FDA Determined
Cause 2		 Software design
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 laura.storms@olympus.com for any additional information concerning this matter.
Quantity in Commerce 408 units
Distribution US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = Gyrus ACMI, Inc.
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