(b)(4).Date sent: 3/14/2024.D4: batch # x7044h.Additional information was requested and the following was obtained: "1.Could you please clarify if there were any patient consequences? nil known 2.Could you please clarify if was any change in the post-operative care of the patient as a result of the event? not known".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: "please clarify how the device "failed to deploy correctly" did clips not feed or advance into the jaws? did device not deploy clip from jaws upon firing? did an unformed clip drop, eject, shoots or spit from the jaws of the device? did device fire scissored clips? this may also include ribbon shaped or x-shaped.Did device fire malformed clips? pear/tear drop shape or clip gap?" 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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