Model note · Surgical Stapler
Ethicon ECHELON FLEX Powered Plus articulating endoscopic linear cutter, 45 mm and 60 mm
The ECHELON FLEX family are single patient use articulating endoscopic linear cutters that lay six staggered rows of staples and cut between them, used in laparoscopic and open general, thoracic, gynaecological, urological and paediatric surgery, including lung, liver, pancreas and bowel work. The Powered Plus versions fire by a battery driven motor rather than hand force, and take ECHELON ENDOPATH reloads with Gripping Surface Technology in colour coded staple heights.
The model
Maker, model and type.
- Maker
- Ethicon Endo-Surgery / Ethicon US, LLC (Johnson & Johnson MedTech)
- Model
- ECHELON FLEX Powered Plus articulating endoscopic linear cutter, 45 mm and 60 mm (also manual ECHELON FLEX ENDOPATH models)
- Device type
- Surgical Stapler
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Staple and cut line | 45 mm model: about 45 mm staples, 42 mm cut; 60 mm model: about 60 mm staples, 57 mm cut | Source |
| Staple rows | Six staggered rows, three each side of the cut line | Source |
| Power | Primary lithium battery pack installed before use; motor driven firing | Source |
| Shaft lengths (60 mm Powered Plus) | 280 mm (PCEE60A), 340 mm (PSEE60A), 440 mm (PLEE60A) | Source |
| Reloads | ECHELON ENDOPATH GST reloads in blue, gold, green, black and white (for example GST60B to GST60W) | Source |
| Shaft movement | Shaft rotates freely both ways; distal articulation for lateral access | Source |
| Sterilisation | Cobalt 60 irradiation, minimum 25 kGy, SAL 10^-6 | Source |
| FDA clearance | 510(k) K202665, decision 15 October 2020, 21 CFR 878.4750, product code GDW, class II; predicates K163454, K160521, K140560 | Source |
Recalls
Known FDA recalls.
- Z-1530-20132013-05-13
ECHELON 60 mm black reload (ECR60T) could give incomplete staple lines from damage during firing.
FDA record - Z-0200-20202019-10-03
Out of specification anvil component in ECHELON FLEX ENDOPATH 60 mm (EC60A).
FDA record - Z-0201-20202019-10-03
Same anvil issue in Powered Plus 60 mm, 280 mm shaft (PCEE60A); related numbers Z-0202-2020 and Z-0203-2020 cover the 440 mm and 340 mm shafts.
FDA record - Z-2326-20212021-06-03
Powered Plus packs labelled 60 mm contained 45 mm devices.
FDA record
Safety
Safety warnings from the record.
- A compromised staple line can cause anastomotic leak, haemorrhage, further surgery or death. Source
- Bunched tissue or obstructions such as clips or stents in the jaws can give an incomplete staple line. Source
- Once the manual override has been used, the device is disabled for further firings and must be replaced. Source
- Do not incinerate, autoclave, EtO sterilise or immerse the lithium battery pack, and keep it below 100 C. Source
- Packs labelled 60 mm were found to contain 45 mm devices in one lot, so check device size at opening. Source
Sources
Where this note comes from.
- J&J MedTech ECHELON FLEX ENDOPATH staplers product page
- Ethicon ECHELON FLEX Powered and Powered Plus in-servicing guide (019927-201109)
- FDA 510(k) summary K202665, ECHELON FLEX Powered Plus
- openFDA recall records, ECHELON FLEX
- openFDA MAUDE problem counts, ECHELON FLEX
Not covered: The stapler is single use with no service manual or error codes; the IFU reload chart with closed staple heights and the articulation angle were not retrieved, and MAUDE counts for the brand also include the powered vascular stapler and manual models.
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