FDA recall Z-2294-2021

Olympus Corporation of the Americas · Class II · device

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

Reason for recall

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2021-06-30
Report date: 2021-08-25
Termination date: 2024-01-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2294-2021