MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 1 S/A CT; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP359H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: the patient was admitted to the hospital at 8:46 due to "4 years after 38+3 weeks of amenorrhea" and was scheduled for surgery at 10:30.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Were there any adverse consequences associated with the patient? did the needle fall into the patient? if so, was the needle piece(s) retrieved during the same procedure? what measures were implemented to retrieve the broken piece? was there any additional tissue damage resulting from the search for the needle piece? what is the surgeon's opinion of the potential consequences for the patient? please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformance's were identified.No product is available for return.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 a patient underwent a cesarean section on (b)(6) 2025 and suture was used.The patient gave birth to a live baby boy at 14:25.The surgeon delivered the placenta, cleaned the uterus, and sutured the uterus.The suture needle broke when the uterus was sutured to the last stitch.The broken needle was found through x-ray and removed.Changed another one to complete the surgery.Additional information has been requested.

• Brand Name: VCL+ VIO 36IN 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.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 21732553
• Report Number: 2210968-2025-03294
• Device Sequence Number: 4109252
• Product Code: GAM
• UDI-Device Identifier: 10705031077881
• UDI-Public: (01)10705031077881(17)290630(10)102D46
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2025

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: VCP359H
• Device Lot Number: 102D46
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2024
• 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: 27 YR
• Patient Sex: Female