MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. EES GENERATOR; INSTRUMENT, ULTRASONIC SURGIICAL

Catalog Number GEN11

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Failure to Anastomose (1028); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Post Operative Wound Infection (2446); Insufficient Information (4580)

Event Date 05/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Publication year of 2021.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: laparoscopic pancreaticoduodenectomy: a retrospective study of 200 cases and the optimization of the single-center learning curve authors: yi-chen tang, qin-qin liu, yong-gang he, jing li, xiao-bing huang citation cite: transl cancer res 2021;10(7):3436-3447.Doi: 10.21037/tcr-21-518 the aim of this retrospective study was to investigate the complications rate curve, possible cause in large cohort studies, and develop a protocol to prevent the severe postoperative complications.Between january 2015 and december 2019, the study included 213 and 204 patients undergoing opd and lpd, respectively.Postoperative outcomes, complications, and complication risk, along with operation time were analyzed, and the learning curve was determined.The 3-0 prolene (wb558 ethicon) was used for the full-thickness suture of the pancreas and outer mucosa of the jejunum.The 5-0 pds ii (w9073 ethicon) was used for the interrupted suture of the pancreatic duct and jejunal mucosa.(vi) reconstruction of hepaticojejunostomy: the 5-0 polydioxanone (vcp397h ethicon) and 5-0 pds ii were chosen for hepaticojejunostomy.Gen11 intelligent energy system (ethicon) and harmonic 1100 shears (ethicon) were used for energy sealing and dissecting.Reported complications included clavien dindo grade iii (n=382 ), pancreatic fistula (n=30 ), anastomotic leakage (n=7 ), hemorrhage (n=34 ), intraperitoneal infection, (n= 40) , delayed gastric emptying (n=55 ) , incision infection (n=20) , lung infection (n=52) death (n=4) in conclusion lpd is safe and effective for patients with pancreatic cancer, and has a long learning curve and improved postoperative complications in 50 cases.This study¿s results will help in reducing the complication rates of the first 50 consecutive cases of lpd.

Manufacturer Narrative

(b)(4).Date sent: 10/20/2022.Additional information was requested and the following was obtained: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain --no h1 upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Brand Name: EES GENERATOR
• Type of Device: INSTRUMENT, ULTRASONIC SURGIICAL
• 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: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15461830
• MDR Text Key: 300315411
• Report Number: 3005075853-2022-06289
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036013952
• UDI-Public: 10705036013952
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GEN11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention