MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP339H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.The suture that uncouples from the needle in the first step through the tissue.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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: the following information was requested, but unavailable: -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, -was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, -is the patient part of a clinical study --> unknown, 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.¿ what is the lot number? 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 Manufacturer Narrative
Product complaint #(b)(4).Corrected h11 from initial medwatch: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6.Component code: g07002 - device not returned.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: ·the needle was immediately removed after the needle fell off.The following information was requested, but unavailable: lot number? =>unknown.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 Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 4/29/2026.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.Additional information: d9, h3, h6.H3 investigational summary: the product was returned to eth for evaluation.Visual inspection revealed that one used needle suture piece and one empty labeled winding former were received for analysis.Product code vcp339.During the visual inspection of the returned sample, the swage and attachment area were noted to be as expected.The suture piece was examined, and body fluids were noted along of the strand.As the suture is absorbable and the duration and conditions of environmental exposure could not be determined, functional testing was not performed.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.Per the conditions of the returned sample, no conclusion could be reached as to what caused the reported complaint.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Additional h3 investigational summary: the product was returned to eth for evaluation.Visual inspection revealed that one empty winding former, one paper lid and one used detached were received for analysis.Product code vcp339.During the visual inspection of the returned needle, the swage and attachment area was noted to be as expected.The barrel hole of the needle was examined under magnification, and no suture remnant was observed.In addition, the suture was not returned for evaluation; therefore, the cause of the reported event could not be determined.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.Per the conditions of the returned sample, no conclusion could be reached as to what caused the reported complaint.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-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22512468
• Report Number: 2210968-2025-08148
• Device Sequence Number: 9247209
• Product Code: GAM
• UDI-Device Identifier: 10705031052475
• UDI-Public: 10705031052475
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 07/15/2025

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: VCP339H
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 04/24/2026
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 07/15/2025; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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