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 Problems Failure to Anastomose (1028); Abdominal Pain (1685); Abscess (1690); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Event date: unk.Batch # unk.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.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.

Event Description

It was reported via journal article title: comparison between stable line reinforcement by barbed suture and non-reinforcement in sleeve gastrectomy: a randomized prospective controlled study, authors: mohamed hany, mohammed ibrahim, citation: obesity surgery.2018; 28: 2157¿2164.Doi: https://doi.Org/10.1007/s11695-018-3175-2.Laparoscopic sleeve gastrectomy (lsg) is now a popular bariatric procedure worldwide with rising prevalence over the last decade.Staple line leak and bleeding are the most dangerous complications of lsg.Staple line reinforcement (slr) by oversewing the staple line was suggested to reduce the incidence of leak and bleeding.The authors designed a randomized controlled prospective study to investigate the value of slr by invaginating the whole staple line using unidirectional absorbable sutures to no slr in lsg.A total of 920 patients undergoing lsg between march 2016 and march 2017 were included in the study.They were prospectively randomized into 2 groups (group a: 460 patients; 153 male and 307 female patients; mean age: 37.8 ± 11.8; bmi: 47.64 ± 7.29 and group b: 460 patients; 167 male and 293 female patients; mean age: 38.04 ± 11.15; bmi: 47.07 ± 7.38).During the surgical procedure in all patients, the greater omentum was dissected off, the greater curvature of the stomach up to the left crus of diaphragm and down to approximately 2¿4 cm from the pylorus, followed by dissection of any posterior gastric adhesions and excision of belsey¿s pad of fat, using the enseal device (ethicon).The authors used a 36-fr bougie for calibration in all patients and echelon flex endopath 60-mm linear stapler (ethicon) for gastric division, starting at 3¿5 cm before the pylorus, up to the angle of his.The authors started gastric stapling using black or green reloads according to the thickness of the antrum, then gold reloads for the body and blue reloads for the fundus compression time of 15s.In both groups, reported complications included bleeding (n-9) which required laparoscopic re-exploration due to hemorrhagic shock and were found to be due to trocar site bleeding in 2 cases in group a; laparoscopic re-exploration and were found to be due to bleeding staple line, which were controlled by surgical clips in 3 cases in group b; and conservative management by blood transfusion in 4 patients in group b; proximal leaks (n-6) in which 2 cases had perigastric and perisplenic collections which were managed by insertion of fully covered self-expandable metallic stents.The patients were discharged after adequate oral fluid intake and improvement of clinical symptoms; four cases with proximal leaks with small pouches containing air, adjacent to the leak point that opacified with oral contrast and emptied again into the stomach, they all were managed by antibiotic therapy with follow-up ct repeated weekly for 1 month with complete resolution; distal leak (n-2) in which in 1 case with small pouches containing air, adjacent to the leak point that opacified with oral contrast and emptied again into the stomach, they all were managed by antibiotic therapy with follow-up ct repeated weekly for 1 month with complete resolution; one case with an abscess related to the staple line at the antrum in which ct-guided pigtail was inserted and removed 2 weeks later after ct confirmed no residual collection; case of persistent or recurrent fever and abdominal pain which required follow-up ct; and case of residual collection which required follow-up ct.Lsg is the principal bariatric procedure at the center with excellent results for weight loss and reduction of comorbidities.Comparing slr by invaginating the whole staple line using unidirectional absorbable sutures to no slr in a relatively large cohort of patients undergoing lsg, in a randomized controlled prospective study, has proved statistically significant value for slr by invaginating sutures.

• 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: 10239729
• MDR Text Key: 201175492
• Report Number: 3005075853-2020-03388
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 06/10/2020

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: 06/10/2020
• Initial Date FDA Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention