Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
| Device Type ID | 5551 |
| Device Name | Operating Room Accessories Table Tray |
| Physical State | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Technical Method | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Target Area | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is |
| Regulation Description | Manual Operating Table And Accessories And Manual Operating Chair 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 | Enforcement Discretion |
| CFR Regulation Number | 878.4950 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FWZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5551 |
| Device | Operating Room Accessories Table Tray |
| Product Code | FWZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Operating Table And Accessories And Manual Operating Chair And Accessories. |
| CFR Regulation Number | 878.4950 [🔎] |
| Device Problems | |
|---|---|
Break | 42 |
Device Operates Differently Than Expected | 19 |
Unintended Movement | 17 |
Device Slipped | 14 |
Loose Or Intermittent Connection | 9 |
Unstable | 6 |
Material Integrity Problem | 5 |
Fracture | 4 |
Use Of Device Problem | 4 |
Detachment Of Device Or Device Component | 4 |
Detachment Of Device Component | 4 |
Device Packaging Compromised | 4 |
Device Handling Problem | 3 |
Off-Label Use | 3 |
Overheating Of Device | 3 |
Insufficient Information | 3 |
Melted | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Product Quality Problem | 3 |
Failure To Adhere Or Bond | 2 |
Defective Component | 2 |
No Apparent Adverse Event | 2 |
Appropriate Term/Code Not Available | 2 |
Noise, Audible | 2 |
Unintended Head Motion | 2 |
Mechanical Problem | 2 |
Device Maintenance Issue | 2 |
Material Deformation | 2 |
Fitting Problem | 1 |
Incorrect Device Or Component Shipped | 1 |
Material Too Rigid Or Stiff | 1 |
Material Separation | 1 |
Device Issue | 1 |
Crack | 1 |
Unintended Arm Motion | 1 |
Packaging Problem | 1 |
Positioning Problem | 1 |
Post | 1 |
Component Falling | 1 |
Disconnection | 1 |
Unintended System Motion | 1 |
Connection Problem | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Failure To Advance | 1 |
Vibration | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Patient-Device Incompatibility | 1 |
| Total Device Problems | 190 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Customed, Inc | I | Dec-16-2014 |
| 2 | Customed, Inc | I | Aug-29-2014 |
| 3 | Integra LifeSciences Corporation | II | Feb-10-2015 |
| 4 | Maquet Cardiovascular Us Sales, Llc | II | Nov-09-2015 |
| 5 | Mizuho OSI | II | Apr-19-2017 |