A sample was not returned and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown; therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.(b)(4).
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A health care professional reported that the valved cannula's is coming out when removing the instruments during several procedure, in the past few months.The trocar cannula's were reinserted and procedures completed with no patient harm.Additional information was requested; however, none has been received to date.
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