The subject device was not returned to olympus for evaluation.The subject device was disposed and would not be returning.The exact cause of the reported event cannot be confirmed.In addition, the risk aid states that the (premature firing of the clip) will cause the clip not able to be used or fired properly however, the scenario would not prevent safe removal and replacement of the device.The instruction manual of the device states: "do not advance or extend the instrument abruptly.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.It could also damage the endoscope, instrument, and/or clip.Do not force the instrument if resistance to insertion is encountered.Reduce the angulation of the endoscope until the instrument passes smoothly.Attempting to force the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope, instrument, and/or clip.
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