Pma/510(k) # k142688.Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4).The device involved in this complaint was not available for return to cook.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony.A definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting, possible causes may that the needle became bent/kinked on insertion into the scope.As the lot number was not provided, a review of manufacturing instructions could not be complete.Prior to distribution, all echo-hd-3-20-c devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The notes section of the instructions for use, which accompanies this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".From the information provided: no adverse effects to the patient have been reported as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
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