Device product
The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The light source contains a microprocessor with software to provide safety features and a user-friendly interface. The laser operates by producing a high current discharge within a chamber that is filled with rare gases and halogen. The discharge produces pulses of UV light, which is amplified by reflecting the energy within the resonating chamber many times. The output is directed to the desired target location by the catheter. A footswitch connected to the light source controls the laser action.
Z-2218-2019
Product summary
- Event
- Event 83348
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-2218-2019
Official wording
Reason: Lasers/Catheters did not calibrate during set-up prior to use.
Code information: Serial Numbers: 0016, 0039, 0044, 0048
Distribution pattern: U.S: CA, PA
Derived failure modes
-
Unknown
Lasers/Catheters did not calibrate during set-up prior to use.