(b)(4).Date sent: 1/10/2024.B3: event year only reported: 2023.D4 batch #: unknown.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: what is meant by the generator was not working? were there any error messages? was the patient being rescheduled to a different date for surgery due to the generator issue that resulted in the procedure not being completed? was another device attempted to be used prior to finishing the surgery prior to completion? was the patient's post-operative care altered in any way due to the generator issues during the procedure? were there any patient consequences? what is the patient's current status? 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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