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

Catalog Number	VCP341H
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
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.Additional information was requested and the following response was provided: -please confirm, is this the correct number of devices that demonstrated the alleged deficiency? they used 6ea of vcp341h and the same comment was made.Lot number? av4265.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Attempts are being made to retrieve the device.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.H6 component code: g07002 ¿ device not returned.
Event or Problem Description
It was reported that a patient underwent a hysterectomy on (b)(6) 2024 and suture was used.The surgeon complained that the thread felt thinner than a caliber 1.The surgery was not delayed due to the reported event.The procedure was successfully completed.There were no adverse patient consequences.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/13/2025.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.H6 component code: g07002 pending evaluation of returned device.Additional information: d4, d9, h3, h4, h6.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.A device has been received, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/24/2025.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.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.One needle suture piece and one winding former outside the foil packet were received for analysis.During the visual inspection of the returned sample, the swage and attachment area were noted as expected.The suture was examined along the strand and the end was observed to be cut probably by a surgical instrument.Besides that, body fluids were found on the strand.Per the condition of the returned sample, the diameter of the suture cannot be measured.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 on the cause of the reported event.As part the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: VCL+ VIO 27IN 1 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paulo 12240 ; BR 12240
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20929400
• Report Number: 2210968-2024-13482
• Device Sequence Number: 12842009
• Product Code: GAM
• UDI-Device Identifier: 10705031052512
• UDI-Public: (01)10705031052512(17)290331(10)AV4265
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2025

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: VCP341H
• Device Lot Number: AV4265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 12/17/2024; 01/13/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/13/2025; 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• 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