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Model Number Z316H |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Product not returned.Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Could you please clarify if the patient suffered from any signs or consequences due to the issue? please provide more details it did not suffer because they used other wires to complete the procedure.No product is available for return.Note: events reported on mw# 2210968-2022-10769, & mw# 2210968-2022-10771.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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Event Description
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It was reported a patient underwent an unknown procedure on an unknown date and suture was used.Thread coming off the needle after handling, used in surgery.No reported adverse patient consequences.
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Manufacturer Narrative
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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, 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.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.
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Manufacturer Narrative
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Product complaint # (b)(4).Date sent to the fda: 6/7/2023.The following additional information was received: event date: 20/jul/2022.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.Related reports: 2210968-2022-10769, 2210968-2022-10770, 2210968-2022-10771.
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Search Alerts/Recalls
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