The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.An exhaustive photo was provided as evidence of the defect, showing a failure of the cannula body material near the clamping area.The complaints' review performed was able to identify no other similar issue on the product part number ra2x-xxx in the 3 years.Thus, the event is isolated.Considering that the lot involved was (b)(4) units distributed worldwide, and no other similar event was recorded either on the affected lot or on the affected code in the last three years, a manufacturing failure of the cannula can be resonably ruled out.However, considering that the defect occurred at the end of the procedure, it cannot be excluded that the material deteriorated progressively during use most likely because of inadvertidely initial rough handling of user.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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