A physician reported clattering abnormal sound was generated when connected, the cutter cutter did not actuate during a cataract/vitrectomy surgery.The condition of aspiration is unknown, the surgery was completed after replacing the product with another one.There was no patient harm.
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One opened probe was received, with a tip protector, in a tray.The sample was visually inspected and found to be nonconforming with the inner cutter in the port and orange/brownish foreign material on the port face and inner cutter.The sample was then functionally tested for actuation, aspiration and cut.The sample was found to be conforming for all functional tests, no noise was observed.A review of the device history record traceable to the lot number obtained from the device¿s rfid (radio frequency identification) tag, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The returned sample was found to be functionally conforming, therefore clattering abnormal sound and actuation failure as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the returned probe was functionally conforming.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.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 further actions are required.The manufacturer internal reference number is: (b)(4).
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