Pma/510(k) # k160229.(b)(4).The device involved in this complaint was not available for return to cook ireland for evaluation.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 review of the manufacturing records for echo-hd-22-ebus-o-c device of lot# c1274566: upon review of complaints the failure mode has not occurred previously with this lot.Prior to distribution, all echo-hd-22-ebus-o-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 (b)(4).From the information provided: the patient did not experience any adverse effects due to this occurrence complaints of this nature will continue to me monitored for potential emerging trends,.
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Per rep - physician attempted to advance needle.Experienced difficulty.Needed to withdraw needle.Unable to withdraw needle into scope.Withdrew scope and needle simultaneously and discovered that a portion of the needle was bent at a 90 degree angle, hence, the reason why the needle would not go back into the catheter.Needle was cut off at distal end and disconnected from scope.During scope cleaning, it was observed that scope damage had occurred.
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