(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: - it was reported that "the issue occurred to several clips in 2 packages".- please confirm the number of clips affected during this procedure.=>12 clips.- if the 2 packages were from different lots, please specify how many clips were affected from each lot number.=> currently, unknown.- package lot number of the clips? currently, unknown.- please provide the applier product code and lot number? =>the applier code is ka200 and lot number is unknown.- please confirm if there is an issue with the applier? =>no.If yes, please create a product complaint and provide the respective reference number(s).=>n/a.- - what suture type and size was used? currently unknown.- when the event occurred, was the suture placed near the hinge of the clip?=>yes.- were you able to lock the clip closed on the suture?=>no.If yes, after it closed, was the clip holding securely fixed on the suture? =>n/a.- was the applier checked for damaged (jaws straight and aligned)? =>yes, there is no damage.- if the clip did not close/hold on the suture, was the clip used in an application where the suture was under tension?=>yes.H6 component code: g07002 device not returned to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Related events captured via: 2210968-2024-02017 2210968-2024-02018.
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