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

Catalog Number	VCP353H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a c-section on (b)(6) 2024 and suture was used.During the procedure, when the surgeon was closing the uterus, the first layer was done and completed.When the surgeon started to make the second layer with taking the first bite, the needle left the thread and fell inside the uterus.The surgeon had to open the patient again to find the needle.The surgery was delayed.The procedure was successfully completed.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6 component code: g07002 device not returned.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 investigation findings: c22 - photo review.H3 investigation summary: 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 labeled as vcp353, a needle and suture dispensed with an apparent detachment of the needle.A clear analysis of the end point of failure or the needle hole could not be performed due to the position of the needle in the photo.Based on the photo review, no conclusion or root cause could be determined.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.The manufacturing records could not be reviewed as the batch number is unknown.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Can you identify the lot number of the product that was used? was the needle piece(s) retrieved during the same procedure? what was done to retrieve the needle piece? for example, another incision, modified surgery? were there any patient consequences? were there any unexpected outcomes or complications as a result of the prolonged surgery time? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.What was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? what instruments were used in this procedure to handle the suture? please confirm: was the needle successfully removed once re-opening the patient? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name?.

• Brand Name: VCL+ VIO 27IN 1 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20183713
• Report Number: 2210968-2024-09465
• Device Sequence Number: 8364364
• Product Code: GAM
• UDI-Device Identifier: 10705031052659
• UDI-Public: 10705031052659
• Combination Product (Y/N): Y
• Initial Reporter Country: TC
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VCP353H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown