| Device Type ID | 5677 |
| Device Name | Forceps |
| 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 | HTD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5677 |
| Device | Forceps |
| Product Code | HTD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 310 |
Device Operates Differently Than Expected | 90 |
Material Fragmentation | 39 |
Component Missing | 20 |
Failure To Adhere Or Bond | 17 |
Detachment Of Device Or Device Component | 9 |
Fracture | 8 |
Bent | 5 |
Material Frayed | 5 |
Detachment Of Device Component | 5 |
Partial Blockage | 4 |
Misassembly By Users | 4 |
Naturally Worn | 4 |
Loose Or Intermittent Connection | 4 |
Corroded | 4 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Insufficient Information | 3 |
Device Or Device Fragments Location Unknown | 2 |
Crack | 2 |
Material Separation | 2 |
Material Deformation | 2 |
Delivered As Unsterile Product | 2 |
Contamination / Decontamination Problem | 2 |
Appropriate Term/Code Not Available | 2 |
Failure To Capture | 2 |
Material Integrity Problem | 2 |
Material Twisted / Bent | 2 |
Device Operational Issue | 1 |
Difficult To Remove | 1 |
Patient-Device Incompatibility | 1 |
Cap | 1 |
Nuts | 1 |
Product Quality Problem | 1 |
Device Inoperable | 1 |
Metal Shedding Debris | 1 |
Failure To Calibrate | 1 |
Tip | 1 |
Insufficient Heating | 1 |
No Pressure | 1 |
Fitting Problem | 1 |
Device-Device Incompatibility | 1 |
Device Issue | 1 |
Separation Failure | 1 |
Component Or Accessory Incompatibility | 1 |
Device Damaged By Another Device | 1 |
Mechanical Jam | 1 |
Positioning Failure | 1 |
Loss Of Power | 1 |
Device Slipped | 1 |
Failure To Align | 1 |
Defective Device | 1 |
Temperature Problem | 1 |
Device Damaged Prior To Use | 1 |
Difficult To Advance | 1 |
Scratched Material | 1 |
Component Falling | 1 |
| Total Device Problems | 583 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baxter Healthcare Corporation | II | Dec-22-2018 |
| 2 | ConvaTec, Inc | II | Mar-21-2019 |