Recall Z-2294-2021 ยท GEX Powered Laser Surgical Instrument
Olympus Corporation of the Americas
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
| Date | Jun 30, 2021 |
| Status | Terminated |
| Reason | Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets |
| Root cause | 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 se |
| Quantity | 408 units |
| Distribution | US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Access Gyrus Acmi, Inc., Jun 3, 2021 |