SOLTIVE Premium SuperPulsed Laser System
Received Jul 29, 2026 · Event occurred Jun 1, 2026
Report 3011050570-2026-00768 · MDR key 50072918
Device
Product problems
- Electrical /Electronic Property Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The customer returned the generator to the service center for evaluation related to a separate issue. During testing, the Field Service Engineer identified the device FCA power supply repair needed at ELE. There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to Olympus for evaluation/inspection.Based on the results of the investigation, the power supply repair was identified. A definitive root cause could not be established. Should additional relevant information become available, a supplemental report will be submitted. Olympus will continue to monitor field performance for this device.