MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. UNK_ENSEAL X1 TISSUE SEALER LARGE JAW; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Catalog Number UNK_ENSEAL X1 TISSUE SEALER LA

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Pain (1994); Insufficient Information (4580)

Event Date 04/05/2020

Event Type  Injury  

Event Description

Title: hemostatic efficacy of an advanced bipolar sealer in open gynecologic, thoracic, and colectomy procedures: a prospective cohort study.Authors: jeanne schilder a, david anderson b, fatima shah c, bryan holcomb a, ahmar shah c, grant fullarton d, shazad ashraf e, scott fegan f, hugh paterson b, michael l.Schwiers g, david w.Singleton g, *, jason r.Waggoner g, raymond fryrear ii g, bruce w.Robb a.Citation: international journal of surgery open (2020);24:57-63.Https://doi.Org/10.1016/j.Ijso.2020.03.007.The purpose of this prospective, multicenter, single-arm, cohort study was to evaluate vessel transection, hemostatic performance and ease of use of the abp device in a post-market clinical setting, in three open procedure groups: colectomy, gynecologic, and thoracic.Between march 13, 2018 and august 30, 2019, a total of 101 patients (33 male and 68 female; mean age was 61.8 (range 28.0-89.0) years) underwent surgery in one of the three procedure groups including 36 colectomy, 44 gynecologic, and 21 thoracic procedures.Among these, 99 subjects completed the study through the final postoperative visit.Elective open colectomy, gynecologic, or thoracic procedures were performed per each institution's standard of care approach, where the abp device (enseal® x1 large jaw tissue sealer, ethicon endo-surgery, inc., cincinnati oh, usa), was utilized for vessel sealing and transection, at 6 total institutions in the united kingdom and usa.Reported complications include minor bleeding at the transection site/hemostasis scale grade 2 (n=21), minor bleeding at the transection site requiring touch-up with the abp test device or monopolar cautery/hemostasis scale grade 3 (n=11), significant bleeding/hemostasis scale grade 4 (n=12), device-related aes which includes hematoma and hypotension (n=1), procedural pain (n=1), and superficial thermal burn (n=1) of which were mild in severity, and procedure-related adverse events (n=122).In conclusion, the advanced bipolar device exhibited effective hemostasis, an acceptable safety profile, and ease of use during colectomy, thoracic, and gynecologic procedures.

Manufacturer Narrative

(b)(4).Date sent: 8/25/2023.B3: publication year of 2020.D4: 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.

• Brand Name: UNK_ENSEAL X1 TISSUE SEALER LARGE JAW
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17624246
• MDR Text Key: 321959976
• Report Number: 3005075853-2023-06089
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015024
• UDI-Public: 10705036015024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172580
• 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: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ENSEAL X1 TISSUE SEALER LA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR.
• Patient Outcome(s): Required Intervention