Visual inspection: it was observed that the distal lever/clamp had deformed.The circular feature of the clamp had flattened.Functional inspection: the device was functionally inspected using a sample decompression tube.The tube did not fit securely onto to clamp due to the deformation.The connection was unstable and the tube was moving.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.From ifu: the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.Per the sales rep, the device was lubricated, it has been used successfully previously and it was in sales rep possession for a few weeks.The instrument is distributed as loaners to multiple sales reps and the exact usage cannot be confirmed.Per manufacturing history review the product is in the field for approximately 2 years.The most likely cause of the reported event based on previous similar events and trend reports is wear after repeated use.
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