CDSCO raises alert for Medtronic EEA Auto Suture Circular Stapler/ Loading unit with DST Series Technology
New Delhi: Citing a malfunctions that could have a wide range of adverse consequences for patients, the Central Drugs Standard Control Organization (CDSCO) has issued a Medical Device Alert for Medtronic's EEA Auto Suture Circular Stapler/ Loading unit with DST Series Technology (Staple).
This Medical Device Alert comes in line with Medtronic's Field Safety Notice, which states that Medtronic is recalling 25mm EEA Autosutur Circular Stapler with DST Series Technology, model numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
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.
Laparoscopy is an operation performed in the abdomen or pelvis using small incisions with the aid of a camera.
The DST Series™ EEA™ stapler Distributed 25mm 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 25mm EEA Auto suture Circular Staplers with DST Series Technology. No other Medtronic products or other sizes of EEA Auto suture Circular Staplers with DST Series Technology are affected by this issue.
Explaining the reason of recall, the CDSCO added that a staple guide not attached to the instrument 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 hemorrhage.
In addition the CDSCO further added that the people who may be affected are patients going for surgical procedures with the DST series EEA stapler used throughout the alimentary tract for the creation of end to end, end-to side, and side-to-side anastomoses in both open and laparoscopics.
