Table 3.
Surgical Stapling System Component Specifications
| Surgical Stapling System (Manufacturer) | System Component (Product Code) | Unit | Circulation Ratio |
|---|---|---|---|
| SUS: ECHELON FLEX™ (Ethicon) | 35 mm power handle and adapter (PVE35A) | Surgery | 1 |
| 60 mm power handle and adapter (PSEE60A) | Surgery | 1 | |
| 35 mm cartridge holder (VASECR35) | Firing | 1 | |
| 45 mm cartridge holder (ECR45G) | Firing | 1 | |
| 60 mm cartridge holder (ECR60W) | Firing | 1 | |
| MUS: Signia™ Stapling Technology (Medtronic) | Power shell to cover power handle (SIGPSHELL) | Surgery | 1 |
| Power handle (SIGPHANDLE) | Surgery | 300 | |
| Adapter (SIGADAPTSTND) | Surgery | 50 | |
| Insertion guide (SIGRIG) | Surgery | 300 | |
| Charging station (SIGSBCHGR) | Surgery | 5000 | |
| 30 mm cartridge holder (EGIA30XXX) | Firing | 1 | |
| 45 mm cartridge holder (EGIA45XXX) | Firing | 1 | |
| 60 mm cartridge holder (EGIA60XXX) | Firing | 1 |
Notes: Circulation ratios indicate how often a device component can be reused and are based on the possible maximum number of uses – for example, SIGPHANDLE has a circulation ratio of 300 meaning that each power handle (SIGPHANDLE) can be reused up to 300 times before needing to be replaced. MUS component circulation ratios are based on useful life estimates.28 The MUS display screen includes status indicators for the power handle (SIGPHANDLE) and adapter (SIGADAPTSTND) to ensure that these instruments cannot be used more than their maximum number of possible uses.29
Abbreviations: mm, millimeter; MUS, multi-use system; SUS, single-use system.