(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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please confirm the number of procedures affected by this issue? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).Please confirm the number of devices affected per procedure.Can you identify the lot number of the product that was used? when did the wire break (in the package, during removal from the package, during handling before use on patient or during use on the patient)? please specify were there any patient consequences? 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.H6.Component code: g07002: device not returned.Related events captured via: 2210968-2024-03583.
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