MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 3-0 S/A SH-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP311H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930)
Date of Event	08/01/2023
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.As no contact information has been provided, no follow up can or will be performed at this time.If further details are received at a later date a supplemental medwatch will be sent.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.H6 component code: g07002 ¿ device not returned.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: chinese and foreign medical research vol.21, no.22 august, 2023.
Event or Problem Description
Title: effect of different reinforcement methods of esophagojejunostomy in laparoscopic-assisted total gastrectomy.The aim of this study is to compare the effects of different esophagojejunostomy reinforcement methods in laparoscopic-assisted total gastrectomy.Between january 2020 to november 2022, 100 patients with gastric cancer received laparoscopic-assisted total gastrectomy in people's hospital.Inclusion criteria (1) gastric cancer in accordance with the "internal medicine".They were divided into group b (n = 50) and group a (n = 50) according to the random number table.In group a, there were 31 males and 19 females, aged 52 ~ 67 years, with mean one of (61.34 plus or minus 3.09) years; staging of gastric cancer: 21 cases of stage ii, 29 cases of stage iii; body mass index of 19 ~ 21 kg/m2, with mean body mass index (20.02 plus or minus 0.39) kg/m2.In group b, there were 28 males and 22 females, aged 51 ~ 68 years, with mean one of (61.42 plus or minus 3.12) years; gastric cancer stages: 22 cases in stage ii and 28 cases in stage iii; body mass index of 19 - 21 kg/m2, with mean body mass index of (20.14 plus or minus 0.35) kg/m2.Laparoscopy-assisted total gastrectomy in both groups (by the same group).Linear cutting-closing ligation was used to cut off the duodenal bulb, and 3-0 absorbable vicryl plus suture (johnson & johnson, qingdao oriental wale medical technology co., ltd., cfda (i) 20163654483, code: vcp311h, suture size: 3-0) was used to strengthen and embed the duodenal stump.In group a, the barbed suture [stratafix spiral pga- pcl, johnson & johnson medical (shanghai) ltd., cfda (i) 20173656635, suture size: 3-0] was used to continuously reinforce the esophagojejunostomy.In group b, the esophago-jejunal anastomosis was reinforced with absorbable vicryl plus suture intermittently and in full thickness.Reported complications are the following: vicryl plus suture (cfda (i) 20163654483, code: vcp311h, suture size: 3-0; ethicon) - anastomotic leakage (n=3) treatment: not reported.- incision infection (n=2) treatment: not reported.- anastomotic bleeding (n=8) treatment: not reported.In conclusion, in laparoscopic-assisted total gastrectomy, the use of barbed suture for continuous reinforcement of esophagojejunostomy can shorten anastomosis reinforcement time and operation time, and reduce the incidence rate of anastomotic bleeding complications.

• Brand Name: VCL+ VIO 27IN 3-0 S/A SH-1
• 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: 22514307
• Report Number: 2210968-2025-08167
• Device Sequence Number: 8736984
• Product Code: GAM
• UDI-Device Identifier: 10705031052192
• UDI-Public: 10705031052192
• 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: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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: VCP311H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/15/2025
• 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