(b)(4).The reported condition that the knife blade was fully extended without the jaws being closed was confirmed.The investigation found that the blade was extended into the knife slot but would not return to home position when the latch and jaws were opened.Upon further examination, the blade was found to be rusted and broken.The rfid chip was scanned and the device was found to be used multiple times on four separate dates.The investigation identified the root cause of the reported event to be multiple uses of a single use device resulting in product failure.The ifu warning states: this product cannot be adequately cleaned and/or sterilized by the user in order to facilitate safe reuse, and is therefore intended for single use.Manufacturing non-conformances were reviewed.No entries pertinent to the customer's report were noted.
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