MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 4-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	VCP397H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Erythema (1840); Scar Tissue (2060); Impaired Healing (2378); Swelling/ Edema (4577)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 2/19/2026.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: (b)(4).Please provide an answer for each patient-event: it was recently reported that "¿ the doctor did not give other treatment measures for the patient's wound except suture removal." ¿ was the suture removed in a routine post-op procedure? or was the suture removed in a reoperation procedure? ¿ was reoperation necessary to remove the suture and re-close the wound? ¿ was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.¿ if medication was required, please clarify if it was prescription strength.¿ please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).--received information as following from sales rep via phone today.Please refer to the additional event information mentioned on note(a-14626651), other information requested is unknown.¿ was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.¿ if medication was required, please clarify if it was prescription strength.¿ what is the most current patient status? ¿ what is the procedure date (dd/mm/yyyy)? ¿ what date did the adverse event occur on (dd/mm/yyyy)? --received information as following from sales rep via phone today.Please refer to the event description, other information requested is unknown.The following information was received: per the hospital's feedback, the specific number of events could not be verified, and the involved conditions included: suture breakage easily occurred during intraoperative suturing; the suture could not be withdrawn after postoperative suture removal, some of the suture remained, the wound healing did not meet expectations.No subsequent adverse event reports have been received.After investigation, the patient underwent thyroid tumor resection in the hospital on (b)(6) 2025.The surgeon used vcp397h for tissue suturing during the surgery (the specific suturing tissue level and suturing method were unknown).The intraoperative suturing was smooth, and no device failure or patient injury was reported.After surgery (specific event date unknown), when the patient returned to the hospital for suture removal, the doctor found that the suture could not be withdrawn, and some of the suture remained.The patient had significant scar hyperplasia, wound redness and swelling, and the healing condition did not meet expectations.The doctor did not give other treatment measures for the patient's wound except suture removal.No subsequent adverse event reports were received.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.
Event or Problem Description
It was reported that a patient underwent a thyroid tumor resection surgery on (b)(6)2025 and suture was used.The patient underwent surgery and suture was used during the surgery.A few days later, when the patient came to the hospital to have the suture removed, it was found that the suture could not be extracted and some of the suture remained.It will lead to significant scar hyperplasia in patients.If the suture is completely removed, the scar hyperplasia in the wound will decrease, and the scar hyperplasia will significantly affect the patient's appearance.Additional information was requested.

• Brand Name: VCL+ VIO 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• 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: 24388096
• Report Number: 2210968-2026-01781
• Device Sequence Number: 18688437
• Product Code: GAM
• UDI-Device Identifier: 10705031052970
• UDI-Public: (01)10705031052970(17)300131(10)1066SK
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K181652
• 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): 02/19/2026

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: VCP397H
• Device Lot Number: 1066SK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• 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