(b)(4).Please find attached the leep 1000 final mdr submission package , regarding all initial mdr's ,and retro review initial mdr's filed for reports of intermittent function during use.The documents included in this package are as follows: leep system investigation summary, leep 1000 tech bulletin cover letter , tech service bulletin (b)(4), project #(b)(4)- leep system 1000 root cause.This concludes coopersurgical' s root cause investigation.Coopersurgical, inc.Will continue to monitor the complaint condition for trending and safety.
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