Event summary: as reported, foreign matter was found within the closed package of a roadrunner the firm hydrophilic wire guide by a distributor.The device was not used in a procedure and did not make patient contact.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.The complainant returned one sealed device to cook for investigation.Upon visual inspection a piece of dark hair was found within the sealed pouch.The hair was free floating within the pouch.A document-based investigation evaluation was performed.One potentially related nonconformance was recorded.All affected devices were reworked.There have been no other reported complaints for this lot number.There is no evidence of additional nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the limited available information, cook has concluded that a manufacturing and quality control deficiency contributed to this event.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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