MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL GENERIC PRODUCT CODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number NSEALXXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Adult Respiratory Distress Syndrome (1696); Renal Failure (2041); Insufficient Information (4580)

Event Date 11/03/2021

Event Type  Injury  

Event Description

It was reported via journal article: title: iatrogenic diaphragmatic hernia with fecopneumothorax following minimally invasive esophagectomy and liver resection.Authors: ammara a.Watkins, md, mph, aditya kalluri, md, phd, alok gupta, md, facs, and sidhu p.Gangadharan, md, mhcm.Citation: jtcvs techniques 2022;11:89-91, https://doi.Org/10.1016/j.Xjtc.2021.10.052.This study describes the management of fecopneumothorax secondary to a diaphragmatic defect caused by liver mobilization.This reports a case of a 65-year-old woman who underwent neoadjuvant chemoradiation and minimally invasive ivor-lewis esophagectomy for esophageal adenocarcinoma.During her minimally invasive ivor-lewis esophagectomy, a3-cm liver lesion was noted in the lateral aspect of segment ii.The left triangular ligament was divided, and the liver lesion was excised using the enseal (ethicon endo-surgery inc) device.The liver lesion revealed a focus of resolving hepatic injury with nodular regenerative hyperplasia, possibly secondary to neoadjuvant treatment, with no malignancy seen.4 years later, she presented with new left shoulder pain.Retrosternal air was mischaracterized as her gastric conduit, her shoulder pain was attributed to arthritis, and she was discharged from the emergency room with pain medication.She represented 3 days later with respiratory distress, renal failure, and lactic acidosis.Chest ¿ray demonstrated a left-sided pneumothorax, intrathoracic bowel, and mediastinal shift.A computed tomography scan showed a left diaphragmatic defect lateral to the conduit¿s course, with herniation of transverse colon into the chest.A left posterolateral thoracotomy was performed in the fifth interspace.Frank stool was removed and the lung was mobilized.A midline laparotomy was also performed, and the diaphragmatic defect was enlarged to enable delivery of the strangulated loop of transverse colon back into the peritoneal cavity.The diaphragmatic defect was then closed with a tension-free closure utilizing figure-of-8 prolene sutures.(ethicon).A segmental colon resection with stapled anastomosis was also performed.The patient had a 7-week inpatient postoperative course and wound complications requiring vacuum therapy, but ultimately returned home independently and remains disease free 1 year following her reoperation.The reported complications included diaphragmatic herniation resulting in fecopneumothorax and morbidity with symptoms such as respiratory distress, renal failure, and lactic acidosis (n=1).This case demonstrates the importance of considering diaphragmatic herniation in any patient with previous esophagectomy or liver mobilization.

Manufacturer Narrative

(b)(4) batch # unk.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/batch number has not been provided.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 author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.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, 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.

• Brand Name: ENSEAL GENERIC PRODUCT CODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15457757
• MDR Text Key: 300277329
• Report Number: 3005075853-2022-06274
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NSEALXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female