Product complaint (b)(4) date sent to the fda: 2/2/2024 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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Additional information was requested, the following was obtained: package lot number of the clips? unknown please provide the applier lot number?=unknown.Please confirm if there is an issue with the applier? yes.If yes, please create a product complaint and provide the respective reference number(s).Pc number of the applier is (b)(4).Please explain how the clips were loading into the applier? the clips could not be loading into the applier.Please confirm if the jaws of the applier are at 90 degree to the surface of the clip cartridge when loading =yes.Was the applier checked for damaged (jaws straight and aligned)? =there is no damage.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)?=>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.Please provide the lot number:=>unknown.Please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).=> the sales rep has already known.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.Related reports: 2210968-2024-00882, 2210968-2024-00883, 2210968-2024-00885, 2210968-2024-00886, 2210968-2024-00887.
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