| Device Type ID | 5495 |
| Device Name | Microscope, Surgical |
| 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 Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4700 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EPT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5495 |
| Device | Microscope, Surgical |
| Product Code | EPT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Microscope And Accessories. |
| CFR Regulation Number | 878.4700 [🔎] |
| Device Problems | |
|---|---|
Electrical /Electronic Property Problem | 18 |
Adverse Event Without Identified Device Or Use Problem | 10 |
Overheating Of Device | 10 |
Device Operational Issue | 8 |
Device Operates Differently Than Expected | 6 |
Use Of Device Problem | 6 |
Electrical Overstress | 5 |
Temperature Problem | 4 |
Thermal Decomposition Of Device | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Component Falling | 3 |
Device Issue | 3 |
Use Of Incorrect Control Settings | 2 |
Device Maintenance Issue | 2 |
Disconnection | 2 |
Light Interference | 2 |
Maintenance Does Not Comply To Manufacturers Recommendations | 2 |
Appropriate Term/Code Not Available | 2 |
Circuit Failure | 2 |
Material Frayed | 1 |
Inadequate Service | 1 |
Device Displays Incorrect Message | 1 |
Connection Problem | 1 |
Device Tipped Over | 1 |
Device Dislodged Or Dislocated | 1 |
Defective Component | 1 |
Material Integrity Problem | 1 |
Product Quality Problem | 1 |
Failure To Service | 1 |
Physical Resistance | 1 |
Human-Device Interface Problem | 1 |
Failure To Conduct | 1 |
Insufficient Information | 1 |
Noise, Audible | 1 |
Defective Device | 1 |
Detachment Of Device Or Device Component | 1 |
Mechanical Problem | 1 |
Unintended Collision | 1 |
Electrical Shorting | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Unintended Movement | 1 |
Component Or Accessory Incompatibility | 1 |
Human Factors Issue | 1 |
Mechanical Jam | 1 |
Misassembly By Users | 1 |
Device Handling Problem | 1 |
| Total Device Problems | 122 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Leica Microsystems, Inc. | II | Sep-14-2018 |
| 2 | Leica Microsystems, Inc. | II | Jul-26-2018 |
| 3 | Seiler Instr. & Mfg. Co. Inc. | II | Apr-02-2018 |