MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Urinary Tract Infection (2120)

Event Date 11/25/2021

Event Type  Injury  

Manufacturer Narrative

(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.Citation: chinese journal of practical gynecology and obstetrics, february 2022, vol.38, no.2; https://doi.Org/10.19538/j.Fk2022020117.

Event Description

Title: application of modified laparoscopic radical trachelectomy in cervical cancer for fertility preservation this study aims to evaluate the safety and feasibility of modified laparoscopic radical trachelectomy to preserve fertility in early-stage cervical cancer.From june 2017 to october 2020, 25 patients with early cervical cancer who received laparoscopic radical trachelectomy + pelvic lymphadenectomy were included in the study.13 patients (mean age 31.8 ± 4.84 years) received traditional laparoscopic surgery and 12 patients (mean age 29.2 ± 3.94 years) received modified laparoscopic surgery.All patients underwent pelvic lymphadenectomy at the beginning of surgery.In the modified laparoscope group, before preparing the vagina for transection, the vaginal wall was sutured with a 2-0 suture (johnson & johnson) purse-string 2 cm below the cervix to avoid tumor exposure.The cervix was cut 5 mm below the uterine canyon, the vagina was cut below the vaginal purse-string suture, and the resected cervix and parametrium were sent for frozen pathological examination, and if the tumor was < 5 mm from the resection margin, the uterus was abandoned, and if the tumor was = 5 mm from the resection margin, the residual cervix was sutured to the vagina for reconstruction.In the traditional laparoscopic group, except a uterine elevator was used and purse-string suture was not performed before vaginal incision.Reported complications included fever (n=4) and urinary tract infection (n=1).In conclusion, the application of modified laparoscopic radical trachelectomy in early-stage cervical cancer is safe and feasible, and whether it can further improve the tumor outcome and pregnancy rate needs to be further confirmed by large randomized controlled trials.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18526936
• MDR Text Key: 333043462
• Report Number: 2210968-2024-00474
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female