| Device Type ID | 5655 |
| Device Name | Motor, Surgical Instrument, Ac-powered |
| 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 Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GEY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5655 |
| Device | Motor, Surgical Instrument, Ac-powered |
| Product Code | GEY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| CFR Regulation Number | 878.4820 [🔎] |
| Device Problems | |
|---|---|
Unintended System Motion | 1381 |
Fail-Safe Problem | 1286 |
Mechanical Jam | 1018 |
Device Inoperable | 396 |
Device Operates Differently Than Expected | 356 |
Noise, Audible | 210 |
Overheating Of Device | 200 |
Fluid Leak | 167 |
Detachment Of Device Or Device Component | 108 |
Control Switches | 95 |
Mechanical Problem | 84 |
Device Stops Intermittently | 72 |
Intermittent Energy Output | 64 |
Detachment Of Device Component | 49 |
Loose Or Intermittent Connection | 43 |
Unexpected Shutdown | 41 |
Positioning Problem | 38 |
Vibration | 37 |
Failure To Power Up | 35 |
Sticking | 29 |
Device Operational Issue | 29 |
Battery | 28 |
Connection Problem | 25 |
Motor | 25 |
Break | 25 |
Defective Component | 24 |
Handpiece | 22 |
Difficult To Position | 22 |
Leak / Splash | 22 |
Loss Of Power | 22 |
Output Below Specifications | 20 |
Component Missing | 13 |
Power Problem | 13 |
Material Twisted / Bent | 13 |
Intermittent Loss Of Power | 12 |
Material Separation | 11 |
Temperature Problem | 11 |
Switch, Push Button | 11 |
Difficult To Remove | 11 |
Battery Problem | 11 |
Switches | 11 |
Failure To Charge | 10 |
Air Leak | 9 |
Material Deformation | 9 |
Incomplete Or Inadequate Connection | 8 |
Component Falling | 8 |
Difficult To Insert | 8 |
Defective Device | 8 |
Naturally Worn | 7 |
No Fail-Safe Mechanism | 7 |
Partial Blockage | 7 |
Smoking | 7 |
Fracture | 7 |
Battery Charger | 6 |
Device Displays Incorrect Message | 6 |
Failure To Shut Off | 6 |
Device Slipped | 5 |
Crack | 5 |
Contamination / Decontamination Problem | 5 |
Hose | 4 |
Physical Resistance | 4 |
Power Conditioning Problem | 4 |
Failure To Disconnect | 4 |
Fitting Problem | 4 |
Material Fragmentation | 4 |
Device Damaged By Another Device | 3 |
Component Incompatible | 3 |
Housing | 3 |
Gears | 3 |
Failure To Adhere Or Bond | 3 |
Bent | 3 |
Material Disintegration | 3 |
Device Remains Activated | 3 |
Self-Activation Or Keying | 2 |
Oscillator | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Failure To Calibrate | 2 |
Screw | 2 |
Unintended Ejection | 2 |
Device Contamination With Body Fluid | 2 |
Controller | 2 |
No Device Output | 2 |
Torn Material | 2 |
Knife | 2 |
Material Rupture | 2 |
Misassembly By Users | 2 |
Device Handling Problem | 2 |
Hole In Material | 2 |
Charger | 2 |
Peeled / Delaminated | 2 |
Fail-Safe Design Failure | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Fuse | 1 |
Joint | 1 |
Knob | 1 |
Dent In Material | 1 |
Contamination Of Device Ingredient Or Reagent | 1 |
Electrical Shorting | 1 |
Failure Of Device To Self-Test | 1 |
Pressure Problem | 1 |
| Total Device Problems | 6312 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | MEDICAMAT S.A. | II | Mar-04-2014 |
| 2 | Nico Corp. | II | Jun-21-2016 |
| 3 | Nico Corp. | II | Sep-15-2015 |
| 4 | The Anspach Effort, Inc. | II | May-04-2017 |
| 5 | The Anspach Effort, Inc. | II | Jun-25-2014 |
| 6 | The Anspach Effort, Inc. | II | Jan-06-2014 |