| Device Type ID | 5512 |
| Device Name | Microscope, Surgical, General & Plastic Surgery |
| Regulation Description | Surgical Microscope And Accessories. |
| 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 | 878.4700 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FSO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5512 |
| Device | Microscope, Surgical, General & Plastic Surgery |
| Product Code | FSO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Microscope And Accessories. |
| CFR Regulation Number | 878.4700 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 15 |
Use Of Device Problem | 10 |
Use Of Incorrect Control Settings | 6 |
Detachment Of Device Component | 5 |
Component Falling | 5 |
Device Fell | 4 |
Device Operates Differently Than Expected | 4 |
Bent | 3 |
Electrical /Electronic Property Problem | 3 |
Device Maintenance Issue | 3 |
Installation-Related Problem | 3 |
Failure To Conduct | 2 |
Break | 2 |
Mechanical Problem | 2 |
Cut In Material | 2 |
Detachment Of Device Or Device Component | 1 |
Misfocusing | 1 |
Fluid Leak | 1 |
Disconnection | 1 |
Mechanical Jam | 1 |
Misassembly By Users | 1 |
Device Handling Problem | 1 |
Patient Device Interaction Problem | 1 |
Optical Problem | 1 |
Invalid Sensing | 1 |
Device Displays Incorrect Message | 1 |
Circuit Failure | 1 |
Appropriate Term/Code Not Available | 1 |
Physical Resistance | 1 |
Device Operational Issue | 1 |
Failure To Service | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 86 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Leica Microsystems, Inc. | II | Apr-15-2016 |