Product complaint # (b)(4).H6 component code: g07002 - device not returned.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.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.Additional information was requested, and the following was obtained via: please confirm the number of "clips that wouldn't stay attached to the suture".How many for lot tb2apb, how many for lot ta2ajq, and how many for sm2apb? 5 for each lot package lot number of the clips? already provided please provide the applier product code and lot number? unknown please confirm if there is an issue with the applier? if yes, please create a product complaint and provide the respective reference number(s).N/a.What suture type and size was used? 3-0 polysorb.When the event occurred, was the suture placed near the hinge of the clip? were you able to lock the clip closed on the suture? if yes, after it closed, was the clip holding securely fixed on the suture? was the applier checked for damaged (jaws straight and aligned)? if the clip did not close/hold on the suture, was the clip used in an application where the suture was under tension? procedure name and date? please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep).Events reported via; 2210968-2023-07724, 2210968-2023-07736,2210968-2023-07737, 2210968-2023-07738, 2210968-2023-07739, 2210968-2023-07740, 2210968-2023-07741,2210968-2023-07747, 2210968-2023-07749, 2210968-2023-07750, 2210968-2023-07760, 2210968-2023-07751, 2210968-2023-07757, 2210968-2023-07758.
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(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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.
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