The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the subject device and the reported incident.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.A review of the instructions for use found: ¿read these instructions completely prior to use.For single use only.Discard any open, unused product.Do not use after the expiration date.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.¿ a review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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