J&J MedTech Launches Ethicon 4000 Stapler With Tech for Future Use With Ottava Surgical Robot

Johnson & Johnson MedTech has launched its Ethicon 4000 stapler in the U.S.

Ethicon 4000 is an advanced surgical stapler designed to manage tissue complexities and provide staple line integrity. This aims to minimize risk of surgical leaks and bleeding complications across multiple specialties.

The surgical stapler features proprietary 3D Staple technology, a redesigned end effector, and streamlined reload options. Both the Ethicon 4000 and Ethicon 3D Reloads are approved for open and laparoscopic surgery, and are planned for future use exclusively on the company’s Ottava robotic surgical system.

J&J MedTech reported the first cases in its clinical trial for the Ottava robot in April 2025. Once the study is finished, the company plans to submit the multi-specialty, soft-tissue surgery robot for FDA de novo authorization.

According to the company, the stapler with reloads addresses common complications and reduced staple line interventions due to bleeding by 23% compared to traditional 2D staples. J&J MedTech cited complications in priority procedures for the strategy behind Ethicon 4000—the burden of cost is estimated to be almost $3 billion in the U.S. alone.

The stapler with reloads delivers staples with offset closure of the staple legs to more evenly distribute compression throughout the staple line. It tots enhanced Gripping Surface Technology (GST), which the company said helps stabilize tissue and reduce tissue slippage.

“We are building on a legacy of innovation and trusted performance in surgical instrumentation to offer new innovations that address some of the most common and costly surgical complications,” said Hani Abouhalka, Company Group Chairman, Surgery, Johnson & Johnson MedTech. “As surgeons work diligently to meet the changing needs of patients, surgical technology must adapt. Johnson & Johnson MedTech is responding by delivering innovation for consistent and reliable experiences across open, minimally invasive, and robotic surgery.”

“The 3D Stapling Technology allows me to more evenly distribute pressure throughout the staple line with more consistency,” added Kelvin D. Higa, MD, FACS, FASMBS, FIFSO, Clinical Professor of Surgery at the UCSF Fresno Medical Education Program, and VP, Chief Medical and Quality Officer at Fresno Heart and Surgical Hospital. “As a surgeon, these technological advancements featured on the ETHICON 4000 will give me greater peace of mind when navigating tissue complexities, even in my most complicated procedures. As Chief Medical and Quality Officer, it is essential we evaluate all devices in the context of safety and value for our organization.”