MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 0 S/A V-34; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP518H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
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.Additional information was requested, and the following was obtained: --received information as following from sales rep today; please refer to the event description, other information requested is unknown.The following information was requested, but unavailable: - were x-rays taken to locate the needle? - was the needle removed from the patient during the same procedure? - what measures were taken to retrieve the needle? - was there any additional tissue damage as a result of searching for the needle? - what is the most current patient status? photo investigation summary = > this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos show a needle used in surgery, which is observed broken in two parts.The body of the needle shows markings from instruments.Based on the photo review, the event reported is confirmed, however 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.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.We value your assistance in providing us an opportunity to evaluate the reported event as all information reported to our company is critical to our continuous improvement efforts.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device and no non conformances/manufacturing irregularities related to the malfunction were identified.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.
Event or Problem Description
It was reported that a patient underwent a lap myomectomy procedure (b)(6) 2025 and a suture was used.On the morning, during surgery, the doctor was suturing the uterine muscle layer when the needle broke in two from the middle.After searching for a long time in the muscle layer, the broken half was found, and after comparing and confirming its integrity, a new suture was unpacked and used.After confirming its integrity, it was continued to be used.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/30/2025.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.Additional information: h6.The following information was received: after investigation, the patient underwent laparoscopic myomectomy on (b)(6) 2025.The operator used the suture (vcp518h) to perform the uterine suturing in the way of continuous suturing.During the suturing, the needle broke (the specific length of broken end of needle was unknown), and the broken needle fell into the patient.The operator immediately visually looked for the broken needle and found it.After removal, the integrity of needle was verified.After the confirmation of no residual foreign body in the patient's body, a new suture was replaced (the specific product information was unknown) to continue the suturing.The subsequent surgery went smoothly.This event did not cause any other harm to the patient except for prolonged operation time (specific extension time was unknown).The patient has been discharged smoothly now.No subsequent adverse events were reported.

• Brand Name: VCL+ VIO 36IN 0 S/A V-34
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22306737
• Report Number: 2210968-2025-07228
• Device Sequence Number: 7924880
• Product Code: GAM
• UDI-Device Identifier: 10705031054042
• UDI-Public: (01)10705031054042(17)290430(10)100Z5B
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: VCP518H
• Device Lot Number: 100Z5B
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• 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 Sex: Unknown