(b)(4).Date of event: only event year known: 2023.Batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: was a leak test performed? if so, what type and what was the result? was the staple line visualized endoscopically during the initial surgical procedure? was there any pre-operative chemo/radiation therapy? how was the leak identified? what was observed at the site of the leak upon reoperation? how was the leak addressed? was there any difficulty noted with the device during the initial procedure? was there any alleged deficiency with the enseal device? what is the current status of the patient? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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