| Device Type ID | 5579 |
| Device Name | Expander, Surgical, Skin Graft |
| Regulation Description | Manual Surgical Instrument For General Use. |
| 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 | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FZW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5579 |
| Device | Expander, Surgical, Skin Graft |
| Product Code | FZW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Failure To Cut | 541 |
Bent | 150 |
Device Operates Differently Than Expected | 108 |
Material Twisted / Bent | 100 |
Mechanical Jam | 39 |
Mechanical Problem | 25 |
Difficult To Remove | 22 |
Break | 15 |
Difficult To Advance | 11 |
Sticking | 11 |
Device Contaminated During Manufacture Or Shipping | 11 |
Physical Resistance / Sticking | 9 |
Dull, Blunt | 8 |
Component Missing | 8 |
Difficult To Open Or Close | 7 |
Appropriate Term/Code Not Available | 7 |
Fracture | 5 |
Material Deformation | 5 |
Difficult To Position | 4 |
Device Inoperable | 4 |
Metal Shedding Debris | 3 |
Disassembly | 3 |
Calibration Problem | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Fitting Problem | 3 |
Detachment Of Device Component | 3 |
Material Too Rigid Or Stiff | 3 |
Separation Failure | 2 |
Loss Of Power | 2 |
Insufficient Information | 2 |
Failure To Align | 2 |
Defective Device | 2 |
Loose Or Intermittent Connection | 2 |
Device Damaged Prior To Use | 2 |
Incorrect Measurement | 2 |
Delivered As Unsterile Product | 2 |
Corroded | 2 |
Power Problem | 2 |
Pin | 1 |
Material Discolored | 1 |
Failure To Service | 1 |
Device Stops Intermittently | 1 |
Defective Component | 1 |
Failure To Advance | 1 |
Improper Device Output | 1 |
Wrinkled | 1 |
Material Disintegration | 1 |
Surgical Graft | 1 |
Device Operational Issue | 1 |
Connection Problem | 1 |
Device Difficult To Maintain | 1 |
Activation Failure Including Expansion Failures | 1 |
Misassembled | 1 |
Use Of Device Problem | 1 |
Power Supply | 1 |
Screw | 1 |
Failure To Disconnect | 1 |
Free Or Unrestricted Flow | 1 |
Device Slipped | 1 |
Cut In Material | 1 |
Crack | 1 |
No Device Output | 1 |
Positioning Failure | 1 |
Partial Blockage | 1 |
Dent In Material | 1 |
| Total Device Problems | 1160 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Molnlycke Health Care, Inc | II | May-03-2017 |