| Device Type ID | 5589 |
| Device Name | Stapler, Surgical |
| 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 | GAG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5589 |
| Device | Stapler, Surgical |
| Product Code | GAG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Mechanical Jam | 57 |
Activation, Positioning Or Separation Problem | 56 |
Misfire | 55 |
Difficult To Open Or Close | 30 |
Failure To Form Staple | 30 |
Adverse Event Without Identified Device Or Use Problem | 14 |
Difficult To Remove | 14 |
Break | 13 |
Failure To Adhere Or Bond | 11 |
Device Operates Differently Than Expected | 10 |
Failure To Cut | 8 |
Failure To Fire | 7 |
Handpiece | 7 |
Fluid Leak | 5 |
Sticking | 5 |
Air Leak | 4 |
Mechanical Problem | 4 |
Detachment Of Device Or Device Component | 4 |
Entrapment Of Device | 4 |
Bent | 4 |
Separation Failure | 3 |
Detachment Of Device Component | 3 |
Leak / Splash | 2 |
Partial Blockage | 2 |
Material Deformation | 2 |
Positioning Failure | 2 |
Firing Problem | 2 |
Insufficient Information | 2 |
Noise, Audible | 2 |
Material Disintegration | 2 |
Device Dislodged Or Dislocated | 2 |
Misassembled | 2 |
Delivered As Unsterile Product | 1 |
Chemical Problem | 1 |
Difficult Or Delayed Positioning | 1 |
Degraded | 1 |
Use Of Device Problem | 1 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Failure To Cycle | 1 |
Material Twisted / Bent | 1 |
Product Quality Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Torn Material | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Failure To Align | 1 |
Defective Device | 1 |
Device Damaged Prior To Use | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Positioning Problem | 1 |
Unsealed Device Packaging | 1 |
Device Packaging Compromised | 1 |
Poor Quality Image | 1 |
Device-Device Incompatibility | 1 |
| Total Device Problems | 389 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | COVIDIEN LLC | II | Oct-04-2018 |
| 2 | Ethicon Endo-Surgery Inc | II | Sep-08-2014 |