| Device Type ID | 5523 |
| Device Name | Lamp, Surgical |
| Regulation Description | Surgical Lamp. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4580 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FTD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5523 |
| Device | Lamp, Surgical |
| Product Code | FTD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Lamp. |
| CFR Regulation Number | 878.4580 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 20 |
Component Falling | 12 |
Detachment Of Device Component | 9 |
Degraded | 7 |
Device Operates Differently Than Expected | 7 |
Use Of Device Problem | 6 |
Break | 5 |
Crack | 4 |
Flaked | 4 |
Detachment Of Device Or Device Component | 2 |
Cover | 2 |
Fracture | 2 |
Human-Device Interface Problem | 1 |
Material Integrity Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Tip | 1 |
Particulates | 1 |
Electrical /Electronic Property Problem | 1 |
Fitting Problem | 1 |
Loss Of Power | 1 |
Out-Of-Box Failure | 1 |
Device Handling Problem | 1 |
Torn Material | 1 |
Device Slipped | 1 |
Device Or Device Fragments Location Unknown | 1 |
| Total Device Problems | 93 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Maquet SAS | II | Jul-19-2018 |
| 2 | Maquet SAS | II | May-25-2018 |
| 3 | Steris Corporation | II | Dec-12-2016 |