Investigation ¿ evaluation.Reviews of the device history record, documentation, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one ncompass nitinol stone extractor was returned for investigation.Upon further inspection, a brown fibrous material was confirmed inside the sealed package.Additionally, a document based investigation evaluation was performed.There is evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the specifications and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded that this event can be traced to manufacturing and a quality control deficiency.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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