(b)(4).Date sent: 10/5/2022.Batch # unk.Additional information was requested and the following was obtained: does surgeon load the clip off of the vessel into the device jaws before applying the device jaws to the vessel and firing? yes.Was there any excessive torquing or twisting of the device at the time of firing? unknown.Was any unexpected resistance felt while firing the trigger? unknown.Were any unexpected noises heard? if so, when did noise occur? unknown.Stated that ¿the device was fired, and the clips would fall off the tissue¿ how was the initial procedure completed if the clips were not holding? a competitive clip applier was used to complete the case.Stated that ¿clips did not form¿ please describe the shape of the clips.¿ they did not close fully (still open in initial clip shape).What is current patient status? unknown.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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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