Reviews of the dimension verification, instructions for use (ifu), manufacturer¿s instructions, 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 prior-to-use hnb5.0-38-100-p-ns-jl3.5 was returned for investigation.The length of the device from strain relief to the distal tip was 102cm.The tip did appear shaved roughly 1cm from the distal most section.However, the tip was still attached and appeared curved to specification.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Additionally, reviews of the manufacturer¿s instructions, specifications, and quality control procedures were conducted, and no gaps were discovered.It should also be noted that an ifu is provided with the device which states to inspect the product after removal from the packaging to ensure no damage has occurred.Based on the information provided and the examination of the returned product, investigation has concluded that while its possible that the device may have come into contact with a sharp object during or after removal from the packaging, this cannot be confirmed.Accordingly, a root cause for this event could not be established.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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