FDA Adverse Event
Malfunction
Summary report: N
HALOGEN LIGHT SOURCE
MDR report key: 25175269
·
Received May 14, 2026
Report
- Report Number
- 3002808148-2026-16071
- Event Type
- Malfunction
- Date Received
- May 14, 2026
- Date of Event
- April 20, 2026
- Report Date
- May 14, 2026
- Manufacturer
- SHIRAKAWA OLYMPUS CO., LTD.
- Product Code
- FCQ
- UDI-DI
- 04953170024511
- PMA / PMN Number
- K993041
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 0
THE CUSTOMER REPORTED REDUCED LIGHT OUTPUT INDICATING THE BULB MAY NEED REPLACEMENT INVOLVING AN OLYMPUS HALOGEN LIGHT SOURCE. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 466280 | HALOGEN LIGHT SOURCE | HALOGEN LIGHT SOURCE | FCQ | SHIRAKAWA OLYMPUS CO., LTD. | CLK-4 | 04953170024511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |