MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 2-0 S/A CT; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP351H
Medical Device Problem Codes	Product Quality Problem (1506); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a c-section procedure in 2025 and suture was used.During the procedure, medical team (maternity medical manager) reports that he and other teams noticed a difference in the structure of the sutures (thinner) than usual.The same questions whether there was any change or change in our making, such as: thread lock, closure, composition.Or something that may have this perception noticed by them.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.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.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional h11: was surgery delayed due to the reported event? unknown.Was procedure successfully completed? unknown.Were fragments generated? unknown.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences: no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study: unknown.(b)(4).Device property of: none.Device in possession of: none.(b)(4).Device property of: none.Device in possession of: none.(b)(4).Device property of: none.Device in possession of: none.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.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.Additional information: h6, d9, h3, d4.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.H3 investigation summary: the product was returned to ethicon for evaluation.One unopened sample was received for analysis.Product code vcp352h.The complaint sample was not received for evaluation.Upon initial inspection of the sample, no external damages were observed on the external packet.In order to evaluate the condition of the returned sample, the packet was opened.The swage and attachment area were noted as expected.The suture was dispensed without problems and examined along the strand no anomalies were observed during the evaluation.The diameters of the sutures were measured, and the results met the requirements.As part of the ethicon quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no anomalies were noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.H3 investigation summary: according to the information received, it was reported pull off - suture needle.The product was returned to ethicon for evaluation.One unopened sample was received for analysis.Product code vcp351h.The complaint sample was not received for evaluation.Upon initial inspection of the sample, no external damages were observed on the external packet.In order to evaluate the condition of the returned sample, the packet was opened.The swage and attachment area were noted as expected.The suture was dispensed without problems and examined along the strand no anomalies were observed during the evaluation.The diameters of the sutures were measured, and the results met the requirements.As part of the ethicon quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no anomalies were noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.
Additional Manufacturer Narrative
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.Corrected data: d9, h3.Sample analysis were previously reported incorrectly.H3 analysis: according to the information received, it was reported suture diameter ¿ undersized.According to the information received, it was reported pull off - suture needle.The product was returned to ethicon for evaluation.One unopened sample was received for analysis.Product code vcp351h.The complaint sample was not received for evaluation.Upon initial inspection of the sample, no external damages were observed on the external packet.In order to evaluate the condition of the returned sample, the packet was opened.The swage and attachment area were noted as expected.The suture was dispensed without problems and examined along the strand no anomalies were observed during the evaluation.The diameters of the sutures were measured, and the results met the requirements.As part of the ethicon quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no anomalies were noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/26/2026.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.Corrected information: h3 investigational summary.H3 investigational summary: the product was returned to ethicon for evaluation.One unopened sample was received for analysis.Product code vcp351h.The complaint sample was not received for evaluation.Upon initial inspection of the sample, no external damages were observed on the external packet.In order to evaluate the condition of the returned sample, the packet was opened.The swage and attachment area were noted as expected.The suture was dispensed without problems and examined along the strand no anomalies were observed during the evaluation.The diameters of the sutures were measured, and the results met the requirements.As part of the ethicon quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no anomalies were noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: VCL+ VIO 27IN 2-0 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paulo 12240 ; BR 12240
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23392121
• Report Number: 2210968-2025-12214
• Device Sequence Number: 21345313
• Product Code: GAM
• UDI-Device Identifier: 10705031052611
• UDI-Public: (01)10705031052611(17)300128(10)AW4138
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VCP351H
• Device Lot Number: AW4138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 01/28/2026; 02/02/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/15/2025; 01/28/2026; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown