Company: Olympus Corporation of the Americas
Date of Enforcement Report: June 30, 2021
Class II

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.

Recall Number:

Z-2294-2021

REASON:

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

RECALLING FIRM/MANUFACTURER:

Olympus Corporation of the Americas

VOLUME OF PRODUCT IN COMMERCE:

408 units

DISTRIBUTION:

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