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

Catalog Number NSEALXXX

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

Patient Problem Seroma (2069)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2018.Batch # unknown.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.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.Additional information requested but not received: does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? as the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.(b)(4).

Event Description

It was reported via literature entitled: feasibility and safety of intraoperative colonoscopy after segmental colectomy and primary anastomosis authors: erika l.Simmerman, d.O.; ray s.King, m.D., ph.D.; p.Benson ham iii, m.D., m.S.; vendie h.Hooks, iii, m.D.Citation: the american surgeon.2018; vol 84.Patients presenting with near-obstructing colon lesions requiring segmental colectomy may benefit from intraoperative colonoscopy (ioc) after primary anastomosis for a more timely and accurate diagnosis of synchronous lesions.The aim of the study is to demonstrate the feasibility and safety of the said technique.A retrospective cohort study of patients undergoing single-stage segmental colectomy and anastomosis at a single tertiary care institution from 2011 to 2013 was performed.A total of 168 consecutive patients underwent segmental colectomy and primary anastomosis of which 78 patients were unable to receive preoperative colonoscopy (poc; 90 patients) because of near-obstructing lesions and received ioc after the anastomosis.In the ioc group, there were 24 male and 54 female patients; in the poc group, there were 38 male and 52 female patients.During the surgical procedure in both groups, an enseal laparoscopic (ethicon), a 30-degree laparoscope, laparoscopic graspers, and a surgeon¿s hand through the gel port were used for resection.In both groups, reported complications included seroma (n-1).In the population of patients unable to receive poc secondary to a partial obstruction, ioc after segmental resection with primary anastomosis is both a feasible and safe strategy for detecting proximal synchronous lesions.This technique does not seem to cause an increase in anastomotic leak rates, postoperative complications, or hospital length of stay.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 9147826
• MDR Text Key: 163311536
• Report Number: 3005075853-2019-22214
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• 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: 09/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1