MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 SUPER JAW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number NSEALX22L

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Tissue Damage (2104); Blood Loss (2597)

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.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.Please confirm which device (ultracision or enseal g2 tissue sealer) was used in patients who experienced bleeding of the ivc, biliary leakage, and intra-abdominal abscess.Does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: a multicenter cohort analysis of laparoscopic hepatic caudate lobe resection author(s): m.Cappelle & d.L.Aghayan & m.J.Van der poel & m.G.Besselink & g.Sergeant & b.Edwin & i.Parmentier & c.De meyere & f.Vansteenkiste & m.D¿hondt citation: langenbeck's archives of surgery (2020) 405:181¿189; doi: https://doi.Org/10.1007/s00423-020-01867-2.This multicenter retrospective cohort study aimed to report on outcomes, clarify technical aspects, and analyze interinstitutional differences of laparoscopic resection of the caudate lobe (lrcl).Between jan200 and may2018, 32 patients (n=20 male; median age of 61 years) with colorectal metastasis (n=22), other (n=4), cholangiocarcinoma (n=1), and benign disease (n=5) underwent laparoscopic hepatic caudate lobe resection.In the procedure, the superficial hepatic parenchyma is transected using an ultrasonic scalpel (ultracision, ethicon endo-surgery inc., cincinatti, oh, usa) or bipolar sealing device (enseal g2 tissue sealer, ethicon endo-surgery inc., cincinnati, oh, usa).One patient was converted to open approach when a bleeding of the inferior vena cava (ivc) was encountered.Postoperative complications included intraabdominal abscess treated with percutaneous drainage and biliary leakage treated with endoscopic stenting.Both patients required readmission without the need of surgical intervention.The most common reason for conversion in llr is bleeding, either of the ivc, major hepatic veins, short veins, or portal triads as reported by others.Increasing the pneumoperitoneum pressure and decreasing the airway pressure can be used to decrease back-bleeding and control the bleeding by bipolar coagulation or an intracorporeal suture.Because of the close relationship of the caudate lobe to the hepatic hilum, the major hepatic veins and the ivc massive hemorrhage are the most feared complications during laparoscopic resection.Laparoscopic resection of the hepatic caudate lobe is technically challenging due to its deep anatomical location and close relationship with the caval vein.

• Brand Name: ENSEAL G2 SUPER JAW
• 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: 10561100
• MDR Text Key: 208559177
• Report Number: 3005075853-2020-04776
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036013808
• UDI-Public: 10705036013808
• Combination Product (y/n): N
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NSEALX22L
• Device Catalogue Number: NSEALX22L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention