MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 2-0 S/A CT-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP739D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
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.H3 investigation summary: the product was returned to ethicon for evaluation.One winding former with seven needles, one needle-suture combination, and three detached sutures were received for analysis.Upon visual inspection of the needles, the swage and attachment area were noted to be as expected.The barrel hole of the needles was examined under magnification, and no suture remnants were noted.The detached sutures were inspected, and the insertion mark could not be observed.During the visual inspection of the needle-suture combination, no anomalies or issues related to pull-off were observed.This product code contains an absorbable suture.Since the sample was received open, the functional test could not be performed due to an undetermined exposure time to the environment.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.Before use on the patient, during the surgery, after unpacking, it was found that one needle in the suture only had a needle and no suture.Changed another one to continue the surgery.During use, one needle experienced the problem of pulling off suture needle.Changed another one to complete the surgery.Upon visual inspection of the needles, the swage and attachment area were noted to be as expected.The barrel hole of the needles was examined under magnification, and no suture remnants were noted.The detached sutures were inspected, and the insertion mark could not be observed.During the visual inspection of the needle-suture combination, no anomalies or issues related to pull-off were observed.This product code contains an absorbable suture.No additional information could be provided.There were no adverse consequences reported.Additional information was requested.

• Brand Name: VCL+ VIO 8X18IN 2-0 S/A CT-1 CR
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21607792
• Report Number: 2210968-2025-02708
• Device Sequence Number: 12978798
• Product Code: GAM
• UDI-Device Identifier: 10705031055179
• UDI-Public: (01)10705031055179(17)5/31/2029(10)101J0D
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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: VCP739D
• Device Lot Number: 101J0D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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