Product complaint # : (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Package lot number of the clips? the lot number of the clips is td2aej.Please provide the applier product code and lot number? the product code is ka200 and lot number is unknown.Please confirm if there is an issue with the applier? no, there is no issue with ka200.If yes, please create a product complaint and provide the respective reference number(s).=n/a.What suture type and size was used? it was 2-0 vicryle.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.They could load the clip into the applier.They set the thread on the tip of the applier, but could not lock and the clip was opened.Even though they squeezed the handle of the applier tightly, they could not fix it.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 provide the lot number: td2aej.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.We regularly contact with sale rep about the device returning.Note: events reported via: mw# 2210968-2023-09233, mw# 2210968-2023-09234,mw# 2210968-2023-09236.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) date sent to the fda: 12/28/2023 a review of the batch manufacturing records was conducted, and no related non-conformances were identified.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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