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 Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4); publication year of 2020; batch #: unk.This report is related to a journal article, therefore, no product will be returned for analysis, and the manufacturing records cannot be reviewed as the lot/batch number has not 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.

Event Description

Title: 'varied application of intercostal transdiaphragmatic ports for laparoscopic hepatectomy'.Author(s): hiromitsu hayashii, yo-ichi yamashitai, hirohisa okabe, katsunori imaii, takaaki higashi, kensuke yamamura, akira chikamoto, toru beppu, hiroshi takamori, hideo baba citation: (2020) varied application of intercostal trans-diaphragmatic ports for laparoscopic hepatectomy.Plos one 15(6): e0234919.Https://doi.Org/10.1371/journal.Pone.0234919.The purpose of this retrospective cohort study was to introduce the varied application of intercostal trans-diaphragmatic ports during laparoscopic hepatectomy, and describe the management of intercostal ports with key technical points.From jan 2013 to dec 2017, a total of 32 patients [n=27 male, n=5 female, mean age 71 years (54-87 years)] had intercostal trans-diaphragmatic ports applied during laparoscopic hepatectomy.Parenchymal transection during laparoscopic hepatectomy was done and an articulating sealing device (enseal; g2, ethicon endo-surgery) was also used during laparoscopic hepatectomy.Complication included post operative bleeding (n=1) in which laparoscopic hemostasis was performed.The ribcage and diaphragm could be overcome as barriers to laparoscopic access by the placement of intercostal ports with minimal access during laparoscopic hepatectomy.The use of an intercostal port and proper management allows for a feasible approach, and safe resection during laparoscopic hepatectomy.

• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10677584
• MDR Text Key: 216409926
• Report Number: 3005075853-2020-05307
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K072177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2020

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
• Device Catalogue Number: NSEALXXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention