Restore Robotics has reported the first human procedures using its remanufactured da Vinci Xi robotic instruments, following FDA clearance for the devices.

The company, based in Panama City Beach, Florida, holds the only FDA clearance to remanufacture da Vinci Xi instruments and currently offers them through Encore Medical Device Repair, its commercial partner. The remanufactured monopolar scissors were used in two separate procedures; one at Hillcrest Medical Center in Tulsa, Oklahoma, and another at Panama City Surgery Center in Florida.

The Tulsa procedure was performed by Dr. Eugene Dickens using the latest da Vinci 5 robotic system, while the Panama City case involved the da Vinci Xi, a widely used platform for robotic-assisted surgeries.
“Our FDA clearance means that the remanufactured instrument is substantially equivalent to a new instrument,” said Clif Parker, CEO of Restore Robotics. “But the real-life use of the remanufactured instrument on a patient is the ultimate proof that our remanufactured instruments are safe and effective.”

Dr. Dickens said the scissors functioned identically to new ones and cited both quality assurance and environmental impact as key benefits. “It worked perfectly. You couldn't tell anything was different from a factory fresh instrument,” he said.

Panama City Surgery Center CEO Mike Madewell reported a similar experience, stating there was “no discernable difference between the Restore instrument and a new one.”

Restore Robotics and Encore are in the process of launching their remanufactured instrument program in large hospital systems nationwide. The company has also stated plans to pursue FDA clearance for additional remanufactured instruments compatible with the da Vinci platform.

The remanufacturing facility for Restore Robotics is located in Henderson, Nevada.

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