Block h6 (device codes): imdrf device code a0401 captures the reportable event of loop wire on end of peg detached.Block h10: the returned endovive safety peg kit push method was analyzed.During visual inspection, it was observed that the loop wire section at the distal end of the feeding tube was detached.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed most likely occurred due to some technique used during procedure.An excess of force applied could have contributed to the detachment of the distal loop.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on event which led to the reported event.
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