HALOGEN LIGHT SOURCE
Received May 28, 2026
Report 3002808148-2026-18355 · MDR key 25319459
Device
Product problems
- Connection Problem
- Activation Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE FAN DOES NOT ROTATE DUE TO A TEMPERATURE FUSE DISCONNECTION SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
THE CUSTOMER RETURNED THE HALOGEN LIGHT SOURCE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT THE FAN DOES NOT ROTATE DUE TO A TEMPERATURE FUSE DISCONNECTION, AND THE LAMP DOES NOT LIGHT UP. THERE WAS NO PATIENT INVOLVEMENT.