MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 5-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP303H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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 via: it was reported that in subsequent operations, similar problem occurred again with product of the same batch number." did the event occur during one or multiple procedures? the event occurred during one procedure.*if this occurred in multiple procedures, please confirm the number of patients affected by the alleged deficiency.1 patient 1 procedure.Have any of these events been previously reported to ethicon? if yes, provide the respective reference number(s).No; please create a new pc file for each patient/event.No need.How many devices demonstrated the reported alleged deficiency on each procedure? 2 same product with same lot in this pc.Did this event contribute to any patient adverse event? if yes, please explain.No.T was reported that "¿in subsequent operations, similar problem occurred again with product of the same batch number." did the event occur during one or multiple procedures? the event occurred during multiple procedures.*if this occurred in multiple procedures, please confirm the number of patients affected by the alleged deficiency.2.Have any of these events been previously reported to ethicon? if yes, provide the respective reference number(s).No.- please create a new pc file for each patient/event.(b)(4).How many devices demonstrated the reported alleged deficiency on each procedure? one.Did this event contribute to any patient adverse event? if yes, please explain.No.
Event or Problem Description
It was reported that a patient underwent a skin tumor resection surgery on (b)(6) 2026 and suture was used.During the procedure, when the doctor was preparing to suture the skin with suture after removing the tumor, it was found that the problem of pulling off suture needle happened and could not be used.Immediately stopped using and replaced with new suture of the same origin, batch number, and model.In subsequent operations, similar problem occurred again with product of the same batch number.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/24/2026.Corrected information: h11 initial report.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: did the event occur during one or multiple procedures? the event occurred during one procedures if this occurred in multiple procedures, please confirm the number of patients affected by the alleged deficiency.1 patient 1 procedure.Have any of these events been previously reported to ethicon? if yes, provide the respective reference number(s).No.Please create a new pc file for each patient/event.No need.How many devices demonstrated the reported alleged deficiency on each procedure? 2 same product with same lot in this pc.Did this event contribute to any patient adverse event? if yes, please explain.No.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.

• Brand Name: VCL+ VIO 27IN 5-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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: 24442027
• Report Number: 2210968-2026-01975
• Device Sequence Number: 10373178
• Product Code: GAM
• UDI-Device Identifier: 10705031052093
• UDI-Public: (01)10705031052093(17)300430(10)108M85
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: VCP303H
• Device Lot Number: 108M85
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/01/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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