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

Catalog Number	VCP341H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle is detached from the thread.Three sutures were used and in three the same happened.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/27/2024.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 returned.H6 component code: c22 - photo analysis.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.H3 photo analysis: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos show one opened foil labeled as vcp341h, used in surgery, with an apparent detachment of the needle.In the photo the needle was observed separated from the suture.Due to the position of the device within the photo, a clear analysis of the device could not be performed.The photo becomes distorted when magnified.The photos were reviewed by a medical safety officer.As per medical safety officer: the photos shows a laparascopic intraoperative image wherein the needle is being held by needle holder.There is no suture visibly attached to the needle.Suture can be seen separate from the needle, left in the surgical field.Image shows an intraoperative image wherein the needle is being held by needle holder.There is no suture visibly attached to the needle.Suture is seen separately with part still in the incision site.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.

• 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: 19807525
• Report Number: 2210968-2024-07521
• Device Sequence Number: 20679336
• Product Code: GAM
• UDI-Device Identifier: 10705031052512
• UDI-Public: (01)10705031052512(17)280904(10)AU9373
• Combination Product (Y/N): Y
• Initial Reporter Country: EC
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: AU9373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2023
• 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