Date of event : date of event was approximated to (b)(6) 2022 as no event date was reported.(b)(4).The returned endovive standard peg kit was analyzed.Product analysis found the kit returned sealed with a brown residue noted inside.The kit was opened and visual inspection was conducted on all internal components: no damage or defect was noted with any of the devices inside the kit.None of the components that contained liquid had any leaks or evidence of damage.Based on the condition of the returned device, engineers determined that the problem observed is most probable that the source of the brown residue came from external to the kit, possibly another product that leaked onto the complaint device in storage.Boston scientific has determined the most probable cause of this complaint is cause traced to transport/storage, which indicates that the problems are traced to inappropriate transport or storage of the device.
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