- Posted by Dextera MIS
- On August 15, 2017
REDWOOD CITY, Calif. – July 6, 2017 – Dextera Surgical Inc. today 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 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 implemented 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% of staplers have been used successfully with no incident. Since the remaining staplers do not pose a safety concern, they will remain in circulation.
Preliminary Results of Operations for Fourth Quarter and Full Year Fiscal 2017
REDWOOD CITY, Calif. – July 6, 2017 – Dextera Surgical Inc. today announced preliminary results for the fourth quarter and full fiscal year 2017.
Dextera Surgical expects to report total product sales including both the cardiac products and the MicroCutter of $940,000 to $960,000 for the fourth quarter of fiscal 2017. Dextera Surgical expects to report approximately $350,000 as well as a $75,000 back order for the MicroCutter 5/80 compared to prior guidance of $600,000 to $700,000 for the fourth quarter of fiscal 2017. For fiscal 2017, Dextera expects to report total product sales of $2.9 million to $3.0 million, including MicroCutter product sales of $1.1 million to $1.2 million.
Previously, Dextera expected MicroCutter sales for fiscal 2017 to be $1.4 million to $1.5 million. The expected decrease in product sales of the MicroCutter 5/80 for the fourth quarter of fiscal 2017 is due in part to a backorder for blue reload cartridges in the first part of the quarter (as announced on the May 4, 2017 quarterly call) as well as the current temporary shipping hold on staplers and reloads. Dextera will record an expense of approximately $150,000 related to the finished goods in stock but not shipped in the fourth quarter of fiscal 2017.