MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 0 S/A CT; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP358H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/03/2025
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.As soon as it was used during the surgery, the problem of the suture pulling off the needle happened, affecting the surgical process.The doctor replaced the suture with another batch number.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6.Component code: g07002 - device not returned.H 6.Investigation findings: c22 ¿ photo investigation 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: received information as following from sales rep via phone: please refer to the event description, other information requested is unknown.The following information was requested, but unavailable: * were there any patient consequences? photo investigation summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows a closed foil labeled as vcp358, and an apparent detachment is visible in the image.A clear analysis could not be performed as the photo becomes distorted when magnified.Based on the photo review, the event reported is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.We value your assistance in providing us an opportunity to evaluate the reported event as all information reported to our company is critical to our continuous improvement efforts.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device and no non-conformances/manufacturing irregularities related to the malfunction were identified.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.

• Brand Name: VCL+ VIO 36IN 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.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22420821
• Report Number: 2210968-2025-07917
• Device Sequence Number: 7138540
• Product Code: GAM
• UDI-Device Identifier: 10705031052710
• UDI-Public: (01)10705031052710(17)290630(10)1022LU
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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: VCP358H
• Device Lot Number: 1022LU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2024
• 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