MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 8X18IN 1 S/A CTXB CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	JB725
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Unspecified Tissue Injury (4559)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.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: arch gynecol obstet.2025 feb;311(2):375-383.Https://doi.Org/10.1007/s00404-024-07706-9.Epub 2024 sep 9.Pmid: 39249518; pmcid: pmc11890381.
Event or Problem Description
Factors affecting gasless reduced-port laparoscopic myomectomy (grp-lm) using a subcutaneous abdominal wall lifting method: a retrospective analysis of a large cohort of 966 cases in japan.The aim of this study is to evaluate the safety, operability, and economic efficiency of this technique, as well as to examine the factors that influence this technique based on relevant patient backgrounds and pathogenesis of uterine fibroids in grp-lm cases.Between 2005 and 2016, gasless reduced-port laparoscopic myomectomy (grp-lm) was performed in 966 patients.The median and range of age and body mass index (bmi) of patients with grp-lm were 37 (22¿55) years and 20.6 (14.5¿32.8) kg/m2, respectively.Eighty-nine patients (9.2% of all patients) were obese with a bmi of 25 or more.Of these, 89 patients (9.2% of all patients) had previous surgeries.The suture of the muscle layer was performed with a single-knot suture using control releasetm synthetic absorbent threads (1-0 and 3-0) or large needles (needle length 48mm, suture size 1: vicryl jb725, ethicon, us).Reported complications are: vicryl jb725 sutures (large needles, needle length 48mm, suture size 1; ethicon) unknown event (n=?).Treatment: not specified but there were patient had blood transfusion with unknown cause grade i and ii clavien-dindo classification subcutaneous emphysema (intraoperative complication) (n=?).Treatment: not reported subcutaneous bleeding (postoperative complication) (n=?).Treatment: not reported infection (postoperative complication) (n=?).Treatment: not reported in conclusion, the gasless reduced-port laparoscopic myomectomy (grp-lm) is a suitable surgical method for myomectomy, because it allows powerful grasping and traction of the fibroid with the tenaculum forceps, and rapid and reliable suture and ligation, despite having only one port for the procedure.In addition, it is economical due to the reduction of manpower and disposable products, as well as cosmetic aspects.

• Brand Name: VCL CT BRD UD 8X18IN 1 S/A CTXB CR
• 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: 22172201
• Report Number: 2210968-2025-06545
• Device Sequence Number: 7788781
• Product Code: GAM
• UDI-Device Identifier: 10705031043961
• UDI-Public: 10705031043961
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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): 06/09/2025

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: JB725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 06/09/2025
• 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: Required Intervention
• Patient Sex: Unknown