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Model Number TPW20 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).H6.Component code: g07002 - device not returned.Attempts have been made to retrieve the device.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.Additional information was requested, and the following was obtained: * could you please clarify if the patient suffered from any signs or consequences due to the issue? no.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Event related to mw # 2210968-2023-05172, mw # 2210968-2023-05174, mw # 2210968-2023-05175, mw # 2210968-2023-05176.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 that a patient underwent a bypass procedure on (b)(6) 2023 and temporary pacing wire was used.The problem of the suture pulling off the needle (straight needle) occurred during use.No adverse patient consequences were reported.Additional information was requested.
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Manufacturer Narrative
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Product complaint # (b)(4).Date sent to the fda: 8/10/2023.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned samples determined that were received thirty-nine unopened samples that pertain to the product code tpw20.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during the evaluation.A functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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 2210968-2023-05172, 2210968-2023-05174, 2210968-2023-05175, and 2210968-2023-05176.
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Search Alerts/Recalls
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