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CDSCO issues medical device alert on Medtronic certain batches of auto suture circular stapler

CDSCO issues medical device alert on Medtronic certain batches of auto suture circular stapler


New Delhi, June 16, 2022:

 

The Central Drugs Standard Control Organisation (CDSCO) has issued an alert notice on US medical technology major Medtronic’s DST series EEA auto suture circular stapler and loading unit with DST Series technology stapler used in open and laparoscopic surgeries as a glitch could result in various adverse impacts to the patients.

The DST Series EEA stapler is used throughout the alimentary tract for the creation of end-to-end, end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.

The company, which issued a Field Safety Corrective Action Notification informed CDSCO that the 25 mm EEA Auto Suture circular staplers with DST Series Technology, with model numbers EEA25, EEAXL25, EEA2535 and EEAXL2535, have the potential for the staple guide to not be securely attached to the instrument. This issue is related only to the 25 mm EEA auto suture circular staplers with DST Series Technology and not other Medtronic products or other sizes of EEA auto suture circular staplers with DST Series Technology are affected by this issue, it said.

A staple guide not attached to the instruments could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples. This could result in delay of treatment, extended hospital stays, unspecified tissue injury, unintended radiation exposure, unexpected medical intervention, foreign body in patient, failure to anastomose and hemorrhagic, it added.

CDSCO has clarified that it has not received any complaints from the market on this issue.

The product, manufactured in its Covidien manufacturing site in US, and imported by India Medtronic Pvt Ltd between June 201 and February 2022 and supplied in the country between June 2017 and May, 2022, are expected to be in the radar of the affected units.

Medtronic has informed the regulator that a voluntary Corrective Action will be implemented to communicate the issue to all consignees who have received affected products, based on the company records, and they will be asked to confirm receipt of FCA notification. The Consignees, including Medtronic field representatives, will be asked to return all unused affected sold product within their possession. Pharmabiz