The device was returned to the apollo device analysis laboratory on 03/nov/2020.Analysis of the device is ongoing.A review of the device labeling notes the following: the current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential events of "helix-did not turn properly" and "helix- could not be removed from tissue" as follows: "warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures." "caution: if resistance is encountered when advancing the helix through the working channel of the endoscope, reduce the endoscope angulation until the device passes smoothly, and ensure that the secondary working channel is not obstructed on the endoscope." "caution: do not depress helix handle button while advancing helix through endoscope." "warnings: do not use a device where the integrity of the sterile packaging has been compromised or if the device appears damaged." warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Ensure that there is sufficient space for the needle to open.Warning: do not introduce the device with the needle body in its open position.
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Supplement #1 submitted on 04/mar/2021.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 03/nov/2020.One tissue helix was returned with blood/tissue present inside the sheath.The knob was pushed down, and it extended the coil as intended, then the knob was pulled up and the coil retracted into the catheter as intended.During rotation of the knob, the turning knob would stick and become intermittent on rotation.Under microscopic analysis, the helix tip appeared to be sharp.The complaint was verified as functional evaluation showed the rotation knob was difficult to turn.
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