MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 4-0 S/A SH-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP771D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a breast surgery procedure on (b)(6) 2024 and suture was used.The patient underwent surgery.During the suturing process, the surgeon found that the connection between the needle and the suture was easy to fall off.Changed another one to complete the surgery.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/16/2024.H6 component code: g07002 - device not returned.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.The following information was requested, but unavailable: were there any patient consequences? please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep).Contacted with the sales rep today via phone, please refer to event description and other information requested is unknown.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 8X18IN 4-0 S/A SH-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: 20461972
• Report Number: 2210968-2024-10784
• Device Sequence Number: 7765946
• Product Code: GAM
• UDI-Device Identifier: 10705031055452
• UDI-Public: (01)10705031055452(17)290228(10)UCMCKR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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: VCP771D
• Device Lot Number: UCMCKR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2024
• 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 Age: 47 YR
• Patient Sex: Female