We have not received the complaint device for evaluation and we were not able to verify the failure mode.Based on the complaint description the distances between clips were up to 0.8-1.0 mm where the ifu recommends placement as close as possible (not more than 0.5 mm between clips).Even though the root cause(s) of the incident remains inconclusive, it is likely that the patient condition (too friable tissue) and improper placement of the clips (distance between clips more than 0.5 mm, and improper apposition of the tissue) during the procedure contributed to the failure.Please note that we were not able to receive any additional information from the distributor in chile, including the date of the incident and lot number.Device not returned for evaluation.
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