MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A CT-2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP334H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 3/19/2025.H6 component code: g07002 - device not returned.H6 component code: c22 - photo analysis.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: - was the needle removed from the patient during the same procedure? - was there any additional tissue damage as a result of searching for the needle? - provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).I was in the room during the procedure and witnessed the process to identify the location of the needle.An x-ray tech was brought into the room to x-ray the patient by placing a plate underneath the patient for the purpose of finding the needle.The needle was located and extracted from the patient through a trocar port.I did observe the needle exiting the port.There was no additional tissue damage noted or discussed after the needle was extracted - dr (b)(6) was in the room and observed the same.H3 photo evaluation: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows a winding former with a suture that has not been dispensed, the needle is not visible in the image.Based on the photo review, no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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.
Event or Problem Description
It was reported that a patient underwent a hysterectomy procedure on (b)(6) 2025 and suture was used.During robotic hysterectomy, the surgical tech was putting a suture down a trocar and when the suture went down the needle went missing.It was hard to find the needle.Intervention was used with x-ray, outside the patient.Near the hip.Case was completed with a different suture still an ethicon product.No patient harm was reported.Device was discarded.Additional information was requested.

• Brand Name: VCL+ VIO 27IN 0 S/A CT-2
• 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: 21644498
• Report Number: 2210968-2025-02963
• Device Sequence Number: 15357240
• Product Code: GAM
• UDI-Device Identifier: 10705031052413
• UDI-Public: (01)10705031052413(17)280831(10)TKMKJH
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2025

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: VCP334H
• Device Lot Number: TKMKJH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2023
• 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