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

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

Patient Problem Insufficient Information (4580)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Title: application of three-mirror combined with transabdominal placement of nasobiliary drainage in elderly patients with extrahepatic bile duct stones.The objective of this study is to investigate the effect of transabdominal nasobiliary drainage with three-mirror combined (laparoscopy combined with choledochoscopy and duodenoscopy) in elderly patients with extrahepatic bile duct stones.Total of 42 elderly patients with choledocholithiasis from (b)(6) 2016 to(b)(6) 2017 in the department of hepatobiliary surgery of the second people's hospital of chengdu were retrospectively analyzed and divided into two groups: nasobiliary group (n = 24) treated with three-mirror combined with transabdominal nasobiliary drainage and t-tube group (n = 18) treated with laparoscopic common bile duct exploration and t-tube drainage.Johnson & johnson absorbable suture was used.Reported complications included postoperative drainage failure (n=1), nasobiliary slippage (n=1) , bile leakage (n=1), in conclusion three-mirror combined with transabdominal nasobiliary drainage is practical for elderly patients with choledocholithiasis, shortening the time with tube, reducing electrolyte imbalance, promoting rapid recovery and improving the quality of life.

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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: doi:10.11952/j.Issn.1007-1954.2018.06.010.Please see article attached.

• 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: 15634434
• MDR Text Key: 302029283
• Report Number: 2210968-2022-08575
• 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
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2022
• 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): Required Intervention