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

Catalog Number NSEALXXX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

Title: influence of a shorter duration of post-operative antibiotic prophylaxis on infectious complications in patients undergoing elective liver resection author: masahiko sakoda, satoshi iino, yuko mataki, yota kawasaki, hiroshi kurahara, kosei maemura, shinichi ueno, shoji natsugoe citation: surgical infections.2017; 18(2).Doi: 10.1089/sur.2016.170.Antibiotic prophylaxis has been recommended to reduce post-operative infectious complications.Post-operative antibiotic prophylaxis has been reported as effective after a digestive operation that is classified as a clean-contaminated surgical procedure.The authors performed a retrospective, non-randomized, and observational analysis of the adequacy of the duration of post-operative antibiotic use and of the risk factors for infectious complications in consecutive patients undergoing liver resection without biliary reconstruction.A total of 208 patients who underwent liver resection without biliary reconstruction were investigated.Liver resection was performed under intraoperative ultrasonographic guidance according to standard techniques.Anatomic resection was performed whenever possible, whereas partial resection was performed in consideration of limited liver functional reserve, anatomic location of the tumor, and benign disease.The exposed structures of 2 mm or less were dissected using enseal.The identified small bile leakage sites on the cut liver surface were repaired by polydioxanone (pds) 4-0 or 5-0 sutures.One or two j-vac 7 mm closed drains were inserted at the end of the operation in the right sub-phrenic space or elsewhere close to the cut surface of liver parenchyma.After closure of the fascia with interrupted pds ii 0 sutures, the surgical incisions in all patients were irrigated with 500 ml saline and the skin was closed using an interrupted pds ii 4-0 sub-cuticular suture.Reported complications included incisional surgical site infections (ssi) in 9 patients, organ/space ssi in 6 patients, catheter-related infections in 2 patients, biliary infections in 4 patients, post-operative bile leakage in 6 patients (1 patient with bile leakage underwent resection of the spiegel lobe for intractable bile leakage and 1 patient underwent re-operation for t-tube drainage due to post-operative perforation of the common bile duct), ileus in 4 patients, intra-abdominal hemorrhage in 4 patients, and hyperbilirubinemia in 2 patients.It was reported that the prevention of post-operative infections after liver resection is obviously important in peri-operative management and it has been believed that antibiotic prophylaxis plays an important role in the prevention of post-operative infections.

Manufacturer Narrative

(b)(4).Additional information received: does the author believe that any of the reported complications are associated with an alleged deficiency with the ethicon device? --- there was no information about the deficiency with ethicon device from the author.

• 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: 7338010
• MDR Text Key: 102366640
• Report Number: 3005075853-2018-08529
• 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,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NSEALXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/14/2018
• Supplement Dates Manufacturer Received: 02/20/2018
• Supplement Dates FDA Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention