Product complaint #: (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: several clips would not close.Additional information has been requested and received.Attempts to obtain the device have been made.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? currently, unknown.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)? currently, unknown.If the clip did not close/hold on the suture, was the clip used in an application where the suture was under tension? currently, unknown.Please perform and document the follow up attempt for product return.We regularly contact with sale rep about the device returning.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Please provide quantity of clips that failed to hold during procedure? a review of the batch manufacturing records was conducted, and no related non-conformances were identified.Note: events reported via: mw# 2210968-2023-09341.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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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Product complaint #(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: please provide quantity of clips that failed to hold during procedure? it is aboout 3 clips.
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