(b)(4).Batch # unk.Investigation summary the analysis results found that the tt012 instrument was received with the sleeve broken.Due to the damages found on the device, a possible cause for this condition is due to improper handling during transit or storage.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.In addition, a photo was received for review.Upon visual inspection of the photo, the following was observed: the photo shows an endopath thoracic device from front view and the device appears to be cracked near of the tip and extends over half of the device.Based on the photo, the event described is confirmed, however no conclusion or root cause could be determined.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.
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