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

Catalog Number	VCPB260H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Holdl13.It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The needle had been detached from the suture.It was not a control release needle.This event was found before use.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Holdl13.Product complaint # (b)(4).D4/g4: device is not distributed in the united states, but is similar to device marketed in the usa.Therefore, (01)gtin is not available.The following information was requested, but unavailable: - please provide the lot number.Unk.H3 investigation summary: the product was returned to ethicon for evaluation.One paper lid, one empty winding former, one detached needle and one dispensed suture were received for analysis.Product code vcpb260h.During the examination, a short suture insertion length was identified at the suture end.Additionally, no suture remnant was observed within the needle barrel hole.Subsequent visual inspection confirmed that the detachment was attributable to an inadequate suture insertion length, which did not conform to the specified acceptance criteria.Based on the information currently available, the short insertion issue was identified as pull out during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.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.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50200498
• Report Number: 2210968-2026-07947
• Device Sequence Number: 5496491
• Product Code: GAM
• UDI-Device Identifier: 10705031056343
• UDI-Public: 10705031056343
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K181652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: VCPB260H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/10/2026
• 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