The navio flat markers, part pfsdv0016 intended for use in treatment were not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed a contributing factor may be customer did not manage product expiration on shelf.No containment or corrective actions are recommended at this time.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.
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