Model note · Surgical Stapler
Medtronic Signia Stapling System
Signia is a reusable, battery powered and microprocessor controlled handle that clamps, articulates and fires Covidien Endo GIA, Tri-Staple 2.0 and Signia reloads through linear or circular adapters. Its Adaptive Firing software measures clamping and firing force and slows firing as force rises. The handle sits in a sterile power shell, and the system includes chargers, an insertion guide and a manual retraction tool for use after a failure.
The model
Maker, model and type.
- Maker
- Covidien LP (Medtronic)
- Model
- Signia Stapling System (powered handle)
- Device type
- Surgical Stapler
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| System components | Signia Power Handle, Power Shell and Linear Adapter; accessories: reusable insertion guide, manual retraction tool, single bay charger, optional sterilisation tray and four bay smart charger | Source |
| Drive and control | Built in battery and microprocessor; push button clamping, articulation and firing; feedback by LEDs, OLED display and tones | Source |
| Adaptive stapling algorithm | Measures force during clamping and firing, keeps it under preset limits and changes firing speed across three force zones | Source |
| Compatible reloads | Endo GIA reloads, Endo GIA with Tri-Staple technology, Tri-Staple 2.0 reloads and Signia loading units with Tri-Staple 2.0 cartridges | Source |
| Real time force gauge | Shown on the OLED for all compatible Covidien reloads from the K201672 software; before that only for intelligent reloads with an ID chip | Source |
| Indications | Abdominal, gynaecological, paediatric and thoracic surgery for resection, transection and anastomosis, including liver substance, hepatic vasculature and biliary structures | Source |
| FDA clearance | K160176 Signia Stapler (April 2016); K201672 new software (July 2020); product code GDW, Class II, 21 CFR 878.4750 | Source |
Recalls
Known FDA recalls.
- Z-0485-20262025-09-25
Small diameter curved tip reload (SIGSDL45CTVT): malformed cover tube press may let internal parts move during firing, causing uncontrolled motion.
FDA record - Z-1457-20242024-02-14
Small diameter curved tip reload (SIGSDS30CTVT) may articulate uncontrollably under some firing conditions.
FDA record - Z-1383-20212021-03-04
Small diameter curved tip reload safety lockout may fail, allowing a second firing of an empty reload.
FDA record - Z-1832-20192019-05-17
Tri-Staple 2.0 reloads for Signia may lack one of two jaw alignment pins, giving incomplete staple formation.
FDA record - Z-2507-20182018-05-22
Tri-Staple 2.0 reloads for Signia may be missing the sled that deploys staples.
FDA record - Z-1237-20182017-12-13
Signia power handle shutting down during use; 2121 handles received a software update.
FDA record
Safety
Safety warnings from the record.
- If the reload lockout fails and an empty reload fires again, the stapler can cut tissue with no staples deployed. Source
- A reload missing its sled will not form a staple line when tissue is divided, risking bleeding or leakage. Source
- Uncontrolled articulation of affected curved tip reloads during firing can disrupt the staple line. Source
- Always have a backup handle and the manual retraction tool available, as recovery after a handle failure may need either. Source
Sources
Where this note comes from.
- FDA 510(k) K201672 summary, Signia Stapler with new software
- Medtronic Signia adapter manual operation quick use guide (US-ST-2500047, 07/2025)
- Medtronic surgical stapling support page
- openFDA recall search, Signia
- openFDA MAUDE problem counts, Signia (Covidien)
Not covered: The Signia user manual on manuals.medtronic.com was not opened, so handle screen messages, LED meanings, charge times, battery life and reprocessing limits are not included and errorCodes is empty. Recall records were read through openFDA; the FDA recall web pages were throttling automated requests at the time of drafting. There are over 20 Signia related recall records, mainly reloads; only representative ones are listed. MAUDE counts are large because the system is widely used and include user and reload issues.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Surgical Stapler