It was reported that during the open liver resection surgery, after 2nd fire , noted the clip malformed.Changed the new one to continue surgery but the jaw pinched off the vessel.Change another product to complete the surgery.There was no patient consequence reported.No additional information can be provided.
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(b)(4).Date sent: 12/22/2023.D4: batch # unk.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.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.A manufacturing record evaluation was performed for the finished device lot number 199c46, and no non-conformances 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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