Five clips from this lot were returned to olympus for evaluation by the user facility.A visual inspection was performed on the received condition and noted that the clip was not returned with the device.The distal tip was checked and noted that the clip inside the device has been deployed.The insertion portion was inspected and found a small kink at the top section of the device.The slider was manipulated and the movement is consistent and normal.This complaint device can not be confirmed as the device was returned with out the clip.The cause of the reported ¿failed to deploy¿ could not be determined at this time.The device will be forwarded to the original equipment manufacturer (oem) for further investigation.If additional information becomes available, this report will be supplemented accordingly.The instruction manual provides warning to mitigate the risk of patient injury and device damage that states, ¿keep the insertion portion of the instrument that extends from the biopsy valve and the insertion portion of the endoscope as straight as possible.Do not perform clipping with the insertion section being coiled.Otherwise, the force exerted on the control section may not convey to the clip adequately during clipping.This could result in reduced performance, making it impossible to close the clip or detach it from the coil sheath after clipping.When forcing the clip against the tissue, do not try to rotate the clip.Doing so may tear tissue inside the body cavity, resulting in patient injury, such as perforation, bleeding, or mucous membrane damage.Do not try to forcibly remove the clip if it becomes caught on the distal end of the coil sheath.Forcible removal of the clip could cause patient injury such as perforation, bleeding, or mucous membrane damage.¿.
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