MAUDE Adverse Event Report: ETHICON INC. STRATAFIX UNKNOWN; SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25)

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

Patient Problem Fever (1858)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

(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.¿ trade name - irgacare® ¿ active ingredient(s) ¿ triclosan ¿ dosage form ¿ suture/solid/parenteral ¿ strength ¿ = 2360 ¿g/m 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).Related events captured via 2210968-2022-08290, 2210968-2022-08291.Citation: minerva urology and nephrology 2021 august;73(4):532-539.Https://doi.(b)(4).

Event Description

Title: totally intracorporeal robotic ileal ureter replacement: focus on surgical technique and outcomes the aim of the present study was to describe our totally intracorporeal robotic ileal ureter replacement technique, reporting perioperative and mid-term results and compare it with previous similar experiences, specifically focusing on technical considerations.During 2019, 3 patients who underwent completely intracorporeal robotic ileal ureter, were included in the study.The surgery was performed using endo-gia 60 mm echelon powered endopath® stapler (ethicon inc., cincinnati, oh, usa) and a double layer 3-0 stratafix running suture.Reported complications include: indocyanine green dye revealed poor perfusion at the level of the first anastomosis requiring lateral ileo-ileal anastomosis was performed twice (n=1) in patient 2 (21-year-old male), fever (n=2) in patient 1 (40-year-old male) and patient 2 and broad-spectrum oral antibiotics were successfully administered with immediate return on normal temperature, and stricture at the level of the ileo-ureter anastomosis and mild flank pain with vas of 3 (n=1) in patient 3 (57-year-old male).In conclusion, complex robotic reconstructive procedures are still considerably challenging.Nevertheless, robot-assisted ileal ureter can be performed with a completely intracorporeal technique with optimal results and a limited complication rate, in selected cases.Further evidence, including randomized controlled trials with an adequate number of patients, are necessary to compare safety and efficacy among different surgical approaches.

• Brand Name: STRATAFIX UNKNOWN
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25)
• 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: 15576873
• MDR Text Key: 301558693
• Report Number: 2210968-2022-08292
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: NA
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• 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: 09/27/2022
• 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
• Patient Age: 40 YR
• Patient Sex: Male