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

Catalog Number UNK_ENSEAL G2 ARTICULATING CUR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 09/21/2022

Event Type  Injury  

Event Description

Title: a comparative study of an integrated ultrasonic/bipolar sealing device versus an articulating bipolar sealing device for laparoscopic liver surgery authors: m.D¿hondt1, a.-l.Provoost1, c.De meyere1, i.Parmentier2, h.Pottel3 and c.Verslype4 citation: hpb 2021, 23 (s3), s674-s751 the aim of this retrospective analysis of a prospectively maintained database is to compare the outcome of thunderbeat (tb), an integrated ultrasonic/bipolar sealing device, versus enseal (es), an articulating bipolar sealing device, in lls.Between september 2011 to september 2020, a total of 352 patients who underwent laparoscopic liver surgery (lls), either by using tb (n=105) or es (n=247), were included in the study.Reported complications include bleeding (n=1.2%) and biliary leak (n=1.6%).In conclusion, the integrated ultrasonic/bipolar sealing device is superior compared to the articulating bipolar sealing device in lls in terms of perioperative blood loss without an increase in complications.

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 there were any ethicon device deficiencies that caused or contributed to the negative patient outcomes or the death? what was the specific cause of the death(s) in the enseal group (0.8%)? would the author/surgeon be interested in speaking with ethicon medical and engineering team regarding this event? 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.

Manufacturer Narrative

(b)(4).Date sent: 12/9/2022.

Event Description

Title: a comparative study of an integrated ultrasonic/bipolar sealing device versus an articulating bipolar sealing device for laparoscopic liver surgery authors: an-lies provoost1 ¿ mathieu d¿hondt1 ¿ edward willems2 ¿ celine de meyere1 ¿ isabelle parmentier3 ¿ anne devooght1 ¿ hans pottel4 ¿ chris verslype5 citation: world j surg (2022); 46:2963¿2972.Https://doi.Org/10.1007/s00268-022-06734-3 the aim of this retrospective study of a prospectively maintained database is to compare an integrated ultrasonic/bipolar sealing devices (sd) versus an articulating bipolar sd in laparoscopic liver surgery (lls).Between december 2013 to september 2020, a total of 352 patients were included in the study: tb (n=105; 64 male and 41 female; median age of 64 [55¿72] years; median bmi of 26.0 [22.6¿29.5]) and es (n=247; 142 male and 105 female; median age of 64 [56¿74] years; median bmi of 25.7 [23.2¿29.4]).The thunderbeat (tb) (olympus europa se & co, hamburg, germany) was used in tb group while enseal (es) (ethicon endo-surgery inc., cincinnati, usa) was used in es group, of which were used for parenchymal transection.The sd were used in combination with cusa (cusa, plainsboro, usa).The monopolar electrocautery and bipolar forceps were used for additional transection and hemostasis.Metal clips and locking polymer clips (hem-o-lok, weck surgical instruments, teleflex medical, durham, usa) were applied on small vessels and bile ducts.Endovascular staplers (endo-gia, medtronic, minneapolis, usa) were used for hepatic veins and large portal pedicles.Bleeding from intrahepatic vessels was handled by absorbable multifilament sutures (vicryl, ethicon, livingstone, uk) or barbed synthetic absorbable monofilament sutures (filbloc, assut europe s.P.A., rome, italy).Hemostatic agents consisted of fibrillar absorbable haemostat (surgicel fibrillartm, ethicon, bridgewater, usa), fibrin sealant patch (tachosil, ethicon, bridgewater, usa), or fibrin glue (tisseel, baxter international, deerfield, usa), which were applied on broad surfaces of diffuse oozing or in expected bleeding sites.A hemostatic matrix (surgiflo, ethicon, bridgewater, usa) was used for aggressive bleeding in a localized site.Reported complications include intraoperative bleeding (n=9), postoperative bleeding (n=3), and biliary leak (n=4).In conclusion, the integrated ultrasonic/bipolar sd is superior to the articulating bipolar sd in lls for intraoperative bl without an increase in complications.

Manufacturer Narrative

(b)(4) date sent: 7/5/2023 additional information was obtained: does the author/surgeon believe that there were any ethicon device deficiencies or malfunctions that caused or contributed to the negative patient outcomes or the death? what was the specific cause of the death(s) in the enseal group (0.8%)? would the author/surgeon be interested in speaking with ethicon medical and engineering team regarding this event? no changes to the file or the reportability were changed with the new information.Received full article.See attached.B3, b5.

• Brand Name: UNK_ENSEAL G2 ARTICULATING CURVED JAW
• 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: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15488474
• MDR Text Key: 300650482
• Report Number: 3005075853-2022-06430
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K072177
• 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,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ENSEAL G2 ARTICULATING CUR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention