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
Z-2294-2021
Product summary
- Event
- Event 88229
- Status
- Terminated
- Classification
- Class II
- Quantity
- 408 units
- Official record key
device-enforcement:Z-2294-2021
Official wording
Reason: Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
Code information: Software Version 2.0 (all serial numbers)
Distribution pattern: US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore
Derived failure modes
-
Unknown
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets