(b)(4).Date sent: 4/11/2024.D4: batch # unk.Additional information was requested and the following was obtained: "how did device not work? did device jammed (not fire clips)? did device not feed clips? did device drop or eject clips? did device sideways feed clips? did device fire malformed clips? did device fire scissored clips? my understanding is it fired scissored clips if other please specify is the current patient status known? not known was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) not known".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.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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