MAUDE Adverse Event Report: Ethicon Inc. Coated VICRYL; Suture, Absorbable, Synthetic

Catalog Number	VCP494G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Corrected information: g 4.Pma/ 510(k) additional information: d 4.Expiration date, d 4.Primary udi number, h 4.Device manufacture date, h 6.Type of investigation additional information was requested, and the following was obtained: 1.If possible, could you please confirm the number of procedures/patients affected by this issue? ans: 1 procedure affected 2.How many devices demonstrated the alleged deficiency? ans: 1 device affected 3.How many devices demonstrated the alleged deficiency on each involved patient event? ans: 1 device affected 4.Were there any patient consequences during any of the cases? ans: no recorded of patient consequences 5.Is the product still available for return? ans: product discarded ,not able to return 6.Please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).Ans: surgeon device history review: a manufacturing record evaluation was performed for the finished device 10csu5 / vcp494g batch number, and no non-conformances 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: Coated VICRYL
• Common Device Name: Suture, Absorbable, Synthetic
• Manufacturer (Section D): Ethicon Inc.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): Ethicon Inc.-GmbH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50274911
• Report Number: 2210968-2026-08193
• Device Sequence Number: 10578528
• Product Code: GAM
• UDI-Device Identifier: 10705031053694
• UDI-Public: 10705031053694
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K181652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: VCP494G
• Device Lot Number: 10CSU5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2026
• 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