| Device Type ID | 5659 |
| Device Name | Dermatome |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| 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 | 878.4820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GFD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5659 |
| Device | Dermatome |
| Product Code | GFD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| CFR Regulation Number | 878.4820 [🔎] |
| Device Problems | |
|---|---|
Failure To Cut | 400 |
Device Operates Differently Than Expected | 165 |
Power Problem | 41 |
Loss Of Power | 37 |
Gas Leak | 36 |
Incorrect Measurement | 31 |
Air Leak | 24 |
Output Problem | 23 |
Calibration Problem | 20 |
Failure To Power Up | 17 |
Device Inoperable | 12 |
Appropriate Term/Code Not Available | 11 |
Device Contaminated During Manufacture Or Shipping | 11 |
Intermittent Loss Of Power | 10 |
Noise, Audible | 10 |
Mechanical Problem | 9 |
Component Missing | 8 |
Device Stops Intermittently | 8 |
Improper Device Output | 6 |
Material Frayed | 6 |
Flaked | 6 |
Break | 5 |
Fitting Problem | 5 |
Detachment Of Device Component | 4 |
Unexpected Shutdown | 4 |
Misassembly By Users | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Misassembled | 3 |
Device Operational Issue | 3 |
Failure To Obtain Sample | 3 |
Sticking | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Fluid Leak | 3 |
Insufficient Information | 3 |
Device Damaged Prior To Use | 3 |
Calibration Error | 2 |
Defective Device | 2 |
Leak / Splash | 2 |
Partial Blockage | 2 |
Device Issue | 2 |
Device Emits Odor | 2 |
Fracture | 2 |
Material Integrity Problem | 2 |
Corroded | 2 |
Vibration | 2 |
Delivered As Unsterile Product | 2 |
Failure To Calibrate | 2 |
Use Of Device Problem | 2 |
Unknown (for Use When The Device Problem Is Not Known) | 2 |
Retraction Problem | 1 |
Failure To Auto Stop | 1 |
Material Split, Cut Or Torn | 1 |
Output Above Specifications | 1 |
Connection Problem | 1 |
Electrical Power Problem | 1 |
Unintended Power Up | 1 |
Electrical /Electronic Property Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Defective Component | 1 |
Electronic Property Issue | 1 |
Product Quality Problem | 1 |
Failure To Adhere Or Bond | 1 |
Inflation Problem | 1 |
Difficult To Remove | 1 |
Sparking | 1 |
Bent | 1 |
Device Reprocessing Problem | 1 |
Infusion Or Flow Problem | 1 |
Material Twisted / Bent | 1 |
Misassembled During Installation | 1 |
Ring | 1 |
Use Of Incorrect Control Settings | 1 |
Mechanical Jam | 1 |
Inaccurate Information | 1 |
Motor | 1 |
Fail-Safe Design Failure | 1 |
Decrease In Pressure | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Electrical Shorting | 1 |
Pressure Problem | 1 |
Blocked Connection | 1 |
No Device Output | 1 |
Overheating Of Device | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Detachment Of Device Or Device Component | 1 |
Naturally Worn | 1 |
Temperature Problem | 1 |
Needle | 1 |
Material Erosion | 1 |
Imprecision | 1 |
Loose Or Intermittent Connection | 1 |
Difficult To Advance | 1 |
Mechanics Altered | 1 |
Switch, Push Button | 1 |
| Total Device Problems | 1014 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Exsurco Medical | II | Jun-26-2018 |
| 2 | KCI USA, INC. | II | Jan-07-2015 |
| 3 | KCI USA, Inc. | II | Sep-29-2014 |
| 4 | Zimmer Surgical Inc | II | Aug-03-2018 |
| 5 | Zimmer Surgical Inc | II | Nov-05-2016 |
| 6 | Zimmer Surgical Inc | II | Aug-04-2016 |