Dextera Surgical has announced that it placed a temporary shipping hold on the MicroCutter 5/80 Stapler and reload cartridges in response to six reports that surgeons were unable to clamp the MicroCutter 5/80 Stapler after inserting a MicroCutter 30 Reload into the stapler prior to or during a surgical procedure. No adverse events or complications have been associated with these reports.
Dextera Surgical has conducted an engineering analysis of the affected lots of staplers and reloads. The company has identified two root causes — one in the stapler and one in the reload cartridge — which prematurely engage the lock-out safety feature within the stapler. The lock-out feature, which results in an inability to clamp the stapler and prevents firing, is a built-in safety feature in the MicroCutter 5/80 Stapler. One root cause is related to a ratchet mechanism in the handle. Dextera Surgical has already implemented changes to the MicroCutter 5/80 Stapler design and new lots of the stapler have been manufactured. Analysis of the blue and white reload cartridges revealed that, intermittently, the reload is not sitting flush within the stapler jaws which then engages the lock-out safety feature prematurely. Dextera Surgical is implementing a solution for the reload cartridges.
To assess the risk to patients, Dextera Surgical conducted extensive in vitro testing of the MicroCutter stapler and reload cartridges. The company also reviewed all prior reported complaints and associated adverse events for the last 12 months for the MicroCutter stapler and blue and white reload cartridges, related to the current configuration of the MicroCutter. A majority of the reports indicate the inability to clamp was identified prior to use in the surgical procedure and Dextera Surgical’s internal testing indicates no increased risk of tissue damage even if the problem is not identified before use in a surgical procedure. Prior to using the MicroCutter 5/80 Stapler, as provided in Dextera Surgical’s instructions for use, users are instructed to clamp and unclamp the stapler to confirm proper loading and to inspect the reload.
After evaluation and analysis of the events and testing of the noted manufacturing lots, Dextera Surgical estimates that approximately 60 percent of staplers have been used successfully with no incident. Since the remaining staplers do not pose a safety concern, they will remain in circulation.
“We are first and foremost committed to patient safety, and quickly implemented a voluntary temporary shipping hold to fully investigate the issue,” says Julian Nikolchev, president and CEO of Dextera Surgical. “While we are disappointed to encounter this issue, we remain steadfast in pursuing our mission to develop this innovative technology to bring smaller and more flexible surgical staplers to the marketplace. Importantly, because the MicroCutter 5/80 Stapler is the only surgical stapler with a five-millimeter diameter and 80 degrees of articulation, we believe that close monitoring of the performance and rapid incremental improvements to both the stapler and reloads is necessary so that we are able to provide this pivotal tool for surgeons who are trying to meet the increasing need for less invasive surgical procedures.”