MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 4-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	VCP451H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) additional information provided: although this operation did not cause serious harm to the patient, it increased the risk of tissue trauma, bleeding, and potential infection, and prolonged the surgical time.On the afternoon of the second day after surgery at 16:10, a postoperative visit was conducted on the patient, who complained of no discomfort.On the fourth day after surgery at 08:50, the patient was discharged with the accompaniment of family members.Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Please clarify, what do you mean by "the needle and suture interface suddenly broke" the needle and suture suddenly broke at the attachment.Did this issue contribute to any patient adverse event? did the needles fall into the patient? if yes, was the needle piece(s) retrieved during the same procedure? were x-rays taken to locate the needle piece(s)? what measures were taken to retrieve the broken piece? was there any additional tissue damage as a result of searching for the needle piece? please refer to the event description, other information requested is unknown.How long was the delay? please specify in minutes.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? 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 event description, other information requested is unknown.A manufacturing record evaluation was performed for the finished device lot number, and no related 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.
Event or Problem Description
It was reported a patient underwent treatment and hospitalization due to preeclampsia, diabetes in pregnancy, scar uterus on (b)(6) 2026 and suture was used.The patient came to the hospital for treatment and hospitalization due to preeclampsia, diabetes in pregnancy, scar uterus, and 39+2 weeks of pregnancy.At 9:00 a.M., the patient received surgery.At 9:55 a.M., when the doctor used the suture to give the puerpera a skin suture, the needle and suture interface suddenly broke, leading to the failure of the original suture operation.When the fracture occurred, the needle body might cause scratches or stabs to the surrounding tissues.Immediately report to the doctor to check the integrity of the needle.At the same time, explore the possible damaged area.After exploration, it was determined that the needle was complete and there was no missing part left in the patient's body.The doctor immediately replaced the new suture to give the puerpera a new suture.10: the surgical incision closure of the 15 minute parturient is completed.Additional information has been requested.

• Brand Name: VCL+ VIO 27IN 4-0 S/A FS-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24520912
• Report Number: 2210968-2026-02288
• Device Sequence Number: 9746393
• Product Code: GAM
• UDI-Device Identifier: 10705031078246
• UDI-Public: (01)10705031078246(17)290831(10)103LS3
• 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): 03/05/2026

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: VCP451H
• Device Lot Number: 103LS3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2024
• 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