| Device Type ID | 5691 |
| Device Name | Table, Surgical With Orthopedic Accessories, Ac-powered |
| Regulation Description | Operating Tables And Accessories And Operating Chairs 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 | 878.4960 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JEA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5691 |
| Device | Table, Surgical With Orthopedic Accessories, Ac-powered |
| Product Code | JEA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Operating Tables And Accessories And Operating Chairs And Accessories. |
| CFR Regulation Number | 878.4960 [🔎] |
| Device Problems | |
|---|---|
Unintended Movement | 34 |
Device Issue | 25 |
Unintended System Motion | 24 |
Mechanical Problem | 19 |
Physical Property Issue | 14 |
Adverse Event Without Identified Device Or Use Problem | 12 |
Insufficient Information | 9 |
Improper Or Incorrect Procedure Or Method | 8 |
Use Of Device Problem | 7 |
Fracture | 6 |
Device Operational Issue | 6 |
Patient-Device Incompatibility | 5 |
Device Operates Differently Than Expected | 5 |
Break | 5 |
Positioning Problem | 5 |
Detachment Of Device Component | 5 |
Device Slipped | 4 |
Device Handling Problem | 3 |
Connection Problem | 3 |
Activation, Positioning Or Separation Problem | 2 |
Migration Or Expulsion Of Device | 2 |
Defective Component | 2 |
Corroded | 2 |
Material Integrity Problem | 2 |
Positioning Failure | 2 |
Human Factors Issue | 2 |
Mechanical Jam | 2 |
Misassembly By Users | 2 |
Material Deformation | 2 |
Defective Device | 2 |
Detachment Of Device Or Device Component | 2 |
Crack | 2 |
Component Falling | 2 |
Disconnection | 1 |
Kinked | 1 |
Malposition Of Device | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Noise, Audible | 1 |
Incomplete Or Inadequate Connection | 1 |
Material Too Rigid Or Stiff | 1 |
Inadequate Or Insufficient Training | 1 |
Pin | 1 |
Decoupling | 1 |
Failure To Advance | 1 |
Ambient Temperature Problem | 1 |
Difficult To Remove | 1 |
Material Twisted / Bent | 1 |
Washer | 1 |
Bent | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Device Tipped Over | 1 |
Degraded | 1 |
Disassembly | 1 |
Component Misassembled | 1 |
Circuit Failure | 1 |
| Total Device Problems | 249 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Steris Corporation | II | Jul-20-2016 |
| 2 | Trumpf Medical Systems, Inc. | II | Nov-10-2016 |
| 3 | Trumpf Medical Systems, Inc. | II | Oct-05-2016 |
| 4 | Trumpf Medical Systems, Inc. | II | Feb-05-2016 |
| 5 | Trumpf Medical Systems, Inc. | II | Jan-06-2015 |
| 6 | Trumpf Medical Systems, Inc. | II | Oct-27-2014 |