As reported for this event by the customer, during a therapeutic procedure for a clinical trial, two of the devices used successively would not release from the clip fixing device when gripping the mucosa and had to be removed by using force.The procedure was completed by using another similar device.There is no harm or adverse impact to the patient.The devices were inspected prior to use with no anomaly noted.After looking into the matter, it was determined that the issue was with the clip and not the clip fixing device.The clip fixing device was new and a clipping test with the device of the same model number had been successful.
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The device has been discarded the event has been evaluated based on historical data.Additional information has been received from customer.This supplemental report is being submitted to provide this information.Please see the updates in sections: g3, g6, h2, h4, h6, and h10.Patient details, including pre-existing medical conditions are not known.The model and serial numbers of the devices used in conjunction with the device at the time of the event is not known.The subject device was manufactured on september 2022 based on the provided 3 digit lot information.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Based on past investigations, it is likely the clip device did not release from the main unit (hx-110qr the clip fixing device) as below: ¿ clipping when the shape and angle of the scope were strict.¿ due to the strict shape, the sliding resistance between the operation wire and the coil sheath increased.¿ due to the increased sliding resistance, the force was not transmitted to the tip side, and the slider could not be pulled until the connecting rod broke.¿ the clip could not be released because the connecting rod did not break.The instructions for use includes the following statements that warn against the issue: ·do not pull out the rotary clip device until it hits the slider of this product and clipping is not completed.It may lead to perforation, major bleeding, mucous membrane damage, etc.·do not pull the slider of this product until it hits the end, and do not operate the angle of the endoscope before clipping is completed.It may lead to perforation, major bleeding, mucous membrane damage, etc.·if the clip does not come off from the rotating clip device, do not forcibly pull out the sheath.It may lead to perforation, major bleeding, mucous membrane damage, etc.·this product is intended to be used only when surgical operations are possible as an emergency measure.In the unlikely event that the clip does not come off the rotating clip device, see "chapter 4 emergency actions".·do not press the clip too much against the desired tissue.The intended performance may not be achieved, such as the clip being deformed and not closing completely.
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