Pma/510(k) # k142688.(b)(4).1 x echo-hd-19-c of lot number c1443812 was returned opened in its original packaging.The device related to this occurrence underwent a laboratory evaluation.The tip of the needle was found to be deformed/bent.Prior to distribution, all echo-hd-19-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).A review of the manufacturing records for echo-hd-19-c of lot number c1443812 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1443812.The notes section of the instructions for use, which accompanies this device instructs the user to inspect the device prior to use : "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use" and "ensure the stylet is fully inserted when advancing the needle into the biopsy site".There is evidence to suggest that the customer did not follow the instructions for use in relation to use of the stylet.The failure of needle tip bent was observed in the laboratory.A definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to user error as the stylet should not be partially removed prior to advancement of the needle into intended targeted site.Complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
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