SOLTIVE™ Premium SuperPulsed TF Laser System

As part of Olympus' post market surveillance of SOLTIVE™ laser use, including a review of customer complaints and adverse events, we have become aware that some clinicians are defaulting to the preset laser values for all clinical procedures when that is not consistent with the instructions for use. Olympus is reminding users that preset treatment parameters may not be appropriate for all patients and are guidelines only. Olympus is sending this reminder after reviewing twenty-eight (28) complaints reported between 2021 to 2023 related to ureteral stone procedures, that described serious injuries.

Recall start date: February 5, 2024