Additional information is provided in sections d.4, d.9, h.3, h.6 and h.10.One opened soft tip cannula in a blister was received for the report of soft tip fell off during a vitrectomy when filling brilliant blue.Sample was visually inspected and found to be nonconforming, soft tip was missing from the cannula.Adhesive was present in the inner diameter of the cannula.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The photos attached to the parent complaint were reviewed by the manufacturing site.The photos are of cannula in an open blister and a tyvek label, the reported product, lot information and product complaint is confirmed.The returned sample was received opened.Therefore, how and when the soft tip of the cannula fell off cannot be determined from this evaluation.A root cause cannot be determined for the complaint as described by the customer.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All assemblies are 100% inspected by trained operators.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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