(b)(4).Date sent: 3/28/2024 b3: unknown, assumed first day of month that complaint was reported d4: batch # x7046v a manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.Additional information was requested and the following was obtained: "no patient consequences." "how did device not work? impossible to release clips normally did device jammed (not fire clips)? yes did device not feed clips? the loaders were apparently well loaded did device drop or eject clips? yes, but after 5 attempts, the clips wouldn't hold.The clips were not securely closed did device sideways feed clips? no did device fire malformed clips? yes did device fire scissored clips? but not with scissors" attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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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