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 Fistula (1862); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 1/31/2020.Date of event: publication year of 2018.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.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.

Event Description

Title : evolution of minimally invasive distal pancreatectomies at a single institution.Author : brian k.P.Goh, ser-yee lee, juinn-huar kam, hui ling soh, peng-chung cheow, pierce k.H.Chow, london l.P.J.Ooi, alexander y.F.Chung, and chung-yip chan.Citation: j minim access surg.2018; 14(2): 140¿145.Doi: 10.4103/jmas.Jmas_26_17.This study aims to study the changing trends and outcomes associated with the adoption of minimally invasive distal pancreatectomy (midp) at a single center.This is a retrospective review of 60 consecutive patients (27 male and 56 female patients; bmi: 16.6 to 35.9; age range: 21 to 79 years old) who underwent midp from september 2006 to november 2016 at a single institution.The operative technique for laparoscopic or robotic pancreatectomies has been described previously.In general, the patient was placed in the reverse trendelenburg position with the left shoulder elevated with or without the legs apart.Various laparoscopic energy devices were utilized such as the harmonic scalpel (ethicon), enseal (ethicon), ligasure, or thunderbeat.Dissection of the pancreas proceeded from the medial to lateral position in most cases except for distal lesions in the pancreatic tail.Reported complications included blood loss (n-4), post-operative pancreatic fistula (n-35) which required percutaneous drainage in 12 patients, and post-operative complications (n-23) which required readmission in 12 patients.It was reported that despite advances in surgical technique and perioperative care, distal pancreatectomy is still reportedly associated with a high morbidity rate.The most common complication after is the post-operative pancreative fistula.This study demonstrated that midp was performed with increased frequency at our institution.There was a statistically significant increase in the frequency of resections performed for asymptomatic tumors and resections performed through robotic assistance over time.There also was a non-significant trend towards a decrease in open conversions and increase in the size of tumors resected.

• 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: 9654939
• MDR Text Key: 189713113
• Report Number: 3005075853-2020-00678
• 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: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• 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: 01/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention