FDA Adverse Event
Malfunction
Summary report: N
COLD LIGHT FOUNTAIN D-LIGHT C/AF SCB
MDR report key: 25176030
·
Received May 14, 2026
Report
- Report Number
- 9610617-2026-01108
- Event Type
- Malfunction
- Date Received
- May 14, 2026
- Report Date
- May 14, 2026
- Manufacturer
- KARL STORZ SE & CO. KG
- Product Code
- OAY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE LIGHT SOURCE IS NOT SWITCHING. PROBLEM DESCRIPTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 627160 | COLD LIGHT FOUNTAIN D-LIGHT C/AF SCB | COLD LIGHT FOUNTAIN D-LIGHT C/AF SCB | OAY | KARL STORZ SE & CO. KG | 20133620-133 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |