—#188172

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

FDA product code: GEX — Powered Laser Surgical Instrument
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K211401
Affected lot / code info: Software Version 2.0 (all serial numbers)

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

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

Timeline

Recall initiated: 2021-06-30
Terminated: 2024-01-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188172. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.