(b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Additional information was requested and the following was obtained: package lot number of the clips? sg2adl.Please confirm if there is an issue with the applier? yes, please see (b)(4).What suture type and size was used? unknown.When the event occurred, was the suture placed near the hinge of the clip? unknown.Were you able to lock the clip closed on the suture? no.Was the applier checked for damaged (jaws straight and aligned)? yes.If the clip did not close/hold on the suture, was the clip used in an application where the suture was under tension? no.Analysis summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample revealed that the xc200 reload (c) was returned with no apparent damaged and it was received empty.As the reload was received empty, we are unable to investigate further the event description.As part of ethicon's quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached on the cause of the reported event.The product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned samples revealed that xc200 reload (a) was received with no apparent damage and seven loose clips were received inside of a container.In addition an opened foil was received along with the clips.The clips were manually loaded and tested for functionality with the test device.Upon functional testing of the clips, the instrument loaded, retained, and deployed the clips as intended.The clips were as intended and conforms to our manufacturing requirements.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The clips performed without any difficulties noted.(b)(4).Related events captured via 2210968-2022-10524, 2210968-2022-10525, 2210968-2022-10526, 2210968-2022-10527, 2210968-2022-10528.
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Product complaint # (b)(4).Date sent to the fda: 1/10/2023.H6 component code: g07002 unable to investigate further.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample revealed that the xc200 reload (b) was returned with no apparent damaged and it was received empty.As the reload was received empty, we are unable to investigate further the event description.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event.The event report could not be confirmed as the reload was received empty.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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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