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

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

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 12/31/2019

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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: https://doi.Org/10.3760/cma.J.Cnl15570-20i9i23i-0i407.

Event Description

Title: comparative study of three methods of bile duct colsurc after laparoscopic common bile duct exploration for choledocholithiasis.The aim of this retrospective study was to explore the clinical value of three methods of bile duct closure after laparoscopic common bile duct exploration.A total of 183 patients (113 male and 70 female; aged 51.20 ± 6 79 years; range, 43 to 65 years) with choledocholithiasis who were admitted from january 2011 to january 2018 were included.Patients were assigned to t-tube drainage group (n=61; 39 men and 22 women; age 50.83 ± 5.65, age range 43 to 64 years), j-tube drainage group (n=59; 36 men and 23 women; age 51.28 ± 6 27 years, age range 45 to 65 years), and phase 1 suture group (n=63; 38 men and 25 women, age 51.4817.63 years, age range 43 to 65 years) on the basis of postoperative closure.In the t-tube drainage group, close the bile duct incision after a stitching operation using ethicon 34 or 4-0 absorbable stitch or non-absorbable mousse stitch.Reported complications include residual stones (n=1), biliary stenosis (n=2), bleeding post-op (n=1), and gallbladder leakage (n=7).In conclusion, phase 1 suture was beneficial to reducing surgical trauma and length of stay compared with t-tube drainage after cholangiocarcinotomy, regular self-ejected single j-tube drainage has a tendency to reduce gallbladder leakage and is worth further exploration.

• Brand Name: SUTURE UNKNOWN
• Type of Device: ABSORBABLE SUTURE THE FOLLOWING:
• 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: 16124739
• MDR Text Key: 306986440
• Report Number: 2210968-2023-00204
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 12/27/2022
• Supplement Dates FDA Received: 01/09/2023
• 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