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

Catalog Number	VCP771D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Unspecified Infection (1930); Speech Disorder (4415); Insufficient Information (4580)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
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.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Citation: j thorac dis.2025 may 30;17(5):3053-3063.Https://doi.Org/10.21037/jtd-2024-2061 epub 2025 may 28.Pmid: 40529765; pmcid: pmc12170051.
Event or Problem Description
Title: long-term outcomes of modified enhanced recovery after surgery (meras) protocols in peri-operative management of minimally invasive esophagectomy.The aim of this study is to compare post-operative morbidity, functional recovery, and hospital stay in patients undergoing esophagectomy with modified eras (meras) protocols versus conventional standard care (sc), and to assess the effect of eras on long-term survival outcomes.Between june 1, 2017 and march 30, 2019, a total of 230 consecutive patients with esophageal carcinoma who underwent esophagectomy.The patients were divided into two groups: the meras group, managed according to modified eras (meras) protocols were using vcp771d (vicryl plus, ethicon), and the standard care (sc) group were using silk sutures (4-0, silk).Reported complications are: vcp771d n=2 anastomotic leakage, treatment: not reported.N=11 vocal cord paresis, treatment: not reported.N=18 pulmonary infection, treatment: not reported.N=1 chylous leakage, treatment: not reported.N=2 readmission, treatment: n/a.In conclusion, the implementation of meras protocols can significantly optimize postoperative recovery, reduce complications, and improve survival outcomes, especially in high-risk esophageal cancer patients.Despite the promising results, the limitations of this study underscore the need for well-designed, multicenter, randomized controlled trials to validate these findings and further refine eras protocols for esophageal carcinoma patients.

• 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.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25127461
• Report Number: 2210968-2026-05053
• Device Sequence Number: 18803203
• Product Code: GAM
• UDI-Device Identifier: 10705031055452
• UDI-Public: 10705031055452
• 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: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: VCP771D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/08/2026
• 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: Other
• Patient Sex: Unknown