(b)(4).Date sent: 3/6/2024 d4: batch # unk 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: "did the device deliver a scissored clip which cut the structure? ¿did the device deliver a properly formed clip which cut the structure? ¿did the clip not feed into the jaws, resulting in the jaws cutting the structure upon firing? ¿how was the structure repaired? ¿did bleeding occur? ¿was blood transfusion required? if so, how much blood was given? ¿were there any patient consequences? ¿what is current patient status? ¿was patient post-op care altered due to the punctured bowel?" an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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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