MAUDE Adverse Event Report: ETHICON INC. COATED VICRYL; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP416H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/4/2026.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.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: do you have any photos available for visual analysis? 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? does a fragment of the needle remain in the patient¿s tissue? if so, is there any plan in place to remove the needle piece in the future? if so, could you please provide the scheduled date for the removal? in which tissue structure was the broken needle located? 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: 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 right hemicolectomy procedure on (b)(6) 2026 and suture was used.During robotic right hemicolectomy procedure, the suture disengaged from the needle and popped off mid-case.The suture could not be immediately located within the surgical field.As a precautionary measure, an intraoperative x-ray of the patient¿s abdomen was performed to locate the missing suture and the procedure time was longer.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/4/2026.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.Additional information was requested, the following was obtained: were there any unexpected outcomes or complications resulting from the prolonged surgery time? - how long, in minutes, did the surgery prolong? not sure, perhaps 20-30 minutes.- which tissue was being sutured when the event occurred? colon - was additional dissection required in other organs/tissues other than the target tissue? no.- was there any change in the patient¿s post operative care due to the prolonged procedure? no.-do you have any photos available for visual analysis? no.Was the needle piece(s) retrieved during the same procedure? yes.What measures were implemented to retrieve the broken piece? x-ray as well as manual search was there any additional tissue damage resulting from the search for the needle piece? not that we know of at this time.- does a fragment of the needle remain in the patient¿s tissue? no.If so, is there any plan in place to remove the needle piece in the future? if so, could you please provide the scheduled date for the removal? in which tissue structure was the broken needle located? what is the surgeon¿s opinion of the potential consequences for the patient?.

• Brand Name: COATED VICRYL
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25068093
• Report Number: 2210968-2026-04813
• Device Sequence Number: 10735492
• Product Code: GAM
• UDI-Device Identifier: 10705031053014
• UDI-Public: (01)10705031053014(17)300930(10)10BT24
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: VCP416H
• Device Lot Number: 10BT24
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 05/04/2026; 05/22/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 05/14/2026; 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2025
• 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