A customer reported trocar was inserted into the eye the surgeon had difficulty removing the trocar introducer from the valved port, and as a result, both the port and trocar introducer would come out of the eye.The surgeon was able to remove the trocar introducer during the procedure as instruments were inserted into the port and removed the issue persists and the port came out with the instruments.It has occurred several times.There was no report of patient harm.
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A sample was not received at the manufacturing site for; therefore, the condition of the product could not be verified.A review of the device history record traceable to the possible lot numbers, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A sample was not received, and the device history record review of the possible lot numbers provided indicated the product was processed and released according to the product¿s acceptable criteria, the root cause for 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.All trocar assemblies are 100% inspected for gage size.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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