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
