Model note · Surgical Stapler
Intuitive SureForm 60 / SureForm 45 Stapler and Reloads
SureForm is Intuitive's single use, fully wristed robotic stapler for the da Vinci X and Xi systems (IS4200 and IS4000). The surgeon clamps and fires it from the console, and each reload lays three staggered staple rows on each side of a knife cut. It comes in 60 mm and 45 mm lengths with straight and curved tip versions, plus an 8 mm SureForm 30 family, all limited to their own reloads.
The model
Maker, model and type.
- Maker
- Intuitive Surgical, Inc.
- Model
- SureForm 60 / SureForm 45 Stapler and Reloads
- Device type
- Surgical Stapler
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Compatible systems | da Vinci IS4000 (Xi) and IS4200 (X) only | Source |
| SureForm 60 reload staple line | 6 rows (3 each side of the cut), 90 staples | Source |
| SureForm 45 reload staple line | 6 rows, 66 staples | Source |
| Reload colours and unformed leg length | White 2.5 mm, Blue 3.5 mm, Green 4.3 mm, Black 4.6 mm | Source |
| Reload construction | Single use cartridge with staples and a stainless steel knife, shipped sterile with a staple retainer | Source |
| Indications | Resection, transection and anastomosis in general, thoracic, gynaecological, urological and paediatric surgery; buttress material allowed | Source |
| FDA clearance | K173721 SureForm 60 (July 2018); K183224 SureForm 45 (January 2019); product codes NAY and GDW, 21 CFR 878.4750 | Source |
Recalls
Known FDA recalls.
- Z-1855-20262026-03-11
8 mm SureForm 30 gray reloads for the curved tip stapler may give an incomplete staple line.
FDA record - Z-0340-20232022-10-07
SureForm 30 curved tip stapler and reloads: possible staple deployment failure and fragment generation.
FDA record - Z-0999-20222022-03-17
SureForm 45, 45 curved tip and 60: tissue pushout during firing; correction letter and user manual addendum.
FDA record - Z-1890-20202019-07-01
SureForm 60 green reloads: manufacturing variation may leave adjacent staples undeployed.
FDA record - Z-1891-20202019-07-01
SureForm 60 black reloads: same manufacturing variation.
FDA record
Safety
Safety warnings from the record.
- Tissue can be pushed out of the jaws during firing, mainly when crossing an existing staple line, leaving cut tissue that is not stapled. Source
- Incomplete staple lines can cause air or anastomotic leaks that may need another procedure. Source
- MAUDE also records detachment, material fragmentation and unintended system motion codes, so inspect the instrument after use and report fragments. Source
Sources
Where this note comes from.
- FDA 510(k) K173721 summary, SureForm 60 and Reloads
- FDA 510(k) K183224 summary, SureForm 45 and Reloads
- openFDA recall search, SureForm
- openFDA MAUDE problem counts, SureForm brand
Not covered: Intuitive's SureForm user manual and addendum were not openly available, so system messages, firing behaviour (such as automatic firing speed control), clamp limits and reprocessing details are not included and errorCodes is empty. Recall records were read through openFDA because FDA's recall pages were throttling automated requests. MAUDE counts for the brand are large and reflect both instrument and reload reports.
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