Catalog Number PDP777D |
Device Problems
Break (1069); Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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: did the needle fall into the patient?=>no.Does a piece of the needle remain in the patient¿s tissue?=>no.The following information was requested, but unavailable: it was reported that the surgeon put the strong force enough to break the needle, could you please confirm it this is referring to a breakage needle?=>no further information is available.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Event related to mw # 2210968-2022-09612.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 ¿g/m.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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 total thyroidectomy procedure on (b)(6) 2022 and suture was used.The needle could not be detached from the suture during interrupted suturing on superficial fascia unless the surgeon put the strong force enough to break the needle.It was a control release needle.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: 12/19/2022.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.H6 component code: g07002 no device problem found.H3 investigational summary the product was returned to ethicon for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one opened sample that pertains to product code pdp777d was returned for analysis with the packaging previously opened and used.The product is a control release, and each packet contains eight strands.Upon visual inspection of the returned sample, five needles were observed with a suture piece attached to the needle and the ends of the sutures were observed to be cut possibly caused by a surgical instrument.A functional test was not performed due to the returned conditions of the samples.In addition, in the same package, there were observed three detached needles without sutures.In all the returned needles, the swage and attachment area were noted to be as expected and no damage, or breakage on the body, tip, or swage area was observed during the evaluation.A functional test was performed, on to needle by resistance, and met the requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the report.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Related reports: 2210968-2022-09611 & 2210968-2022-09611.
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Manufacturer Narrative
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(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.Photo analysis summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos show devices with needle attached to suture segments.Please refer to the previously reported device analysis for full analysis details and conclusion.As part of the ethicon endo surgery quality process, all devices are manufactured, inspected, and released to approved specifications.H6 component code: g07002 - device photo.Related events captured via 2210968-2022-09611 and 2210968-2022-09612.
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Manufacturer Narrative
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Product complaint # (b)(40.Date sent to the fda: 7/31/2023.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.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.Ten unopened samples were returned that pertain to product code pdp777d.The product code is control release.In order to evaluate the condition of the returned samples, the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no anomalies were observed during evaluation.The needles were tested by resistance test to needle and met the requirements.In addition, the functional test was performed, and the pull force result meet with the requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of 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.
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Manufacturer Narrative
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Product complaint #(b)(4).Date sent to the fda: 5/18/2023.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.The following additional information was received: qty of product involved: 2 to 1.Qty to be returned: 2 to 11.The following additional information was requested: product evaluations indicate that 2 actual samples have been returned.If the quantity involved should be 1, please provide further explanation.Are the additional samples being returned unopened representative samples? related reports: 2210968-2022-09611 and 2210968-2022-09612.
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Manufacturer Narrative
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(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.Additional information was requested, and the following was obtained: product evaluations indicate that 2 actual samples have been returned.If the quantity involved should be (b)(4), please provide further explanation: the quantity is (b)(4).Are the additional samples being returned unopened representative samples? yes.Two actual samples were returned for evaluation under this complaint.However, unopened samples will be returning additionally.Related reports: 2210968-2022-09612.
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Manufacturer Narrative
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Product complaint # (b)(4).Date sent to the fda: 6/28/2023.Additional information was requested, the following was obtained: how many additional unopened are going to be returned?: 11.Have those unopened representative samples been shipped? please provide any tracking information.The device has been received at sukagawa and will be shipped.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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Search Alerts/Recalls
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