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

Catalog Number NSEALXXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Date 12/02/2022

Event Type  Injury  

Manufacturer Narrative

Pc-(b)(4).Date sent: 7/5/2023 b3: publication year of 2022 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.

Event Description

Title: comparison of surgical outcomes of adnexectomy by vaginal natural orifice transluminal endoscopic surgery (vnotes) versus single-port access (spa) surgery authors: jihee jung, joseph j.Noh , jungeun jeon, chi-son chang and tae-joong kim.Citation cite: j.Pers.Med.2022, 12, 1996.Https://doi.Org/10.3390/jpm12121996.The objective of the pilot study was to compare operative outcomes between vaginal natural orifice transluminal endoscopic surgery (vnotes) and single-port access (spa) adnexectomy.Subjects were patients who underwent adnexectomy for benign ovarian disease, from november 2019 to may 2021.A total of 12 patients underwent vnotes adnexectomy, and 55 patients received spa laparoscopic adnexectomy.A 1:2 matching was performed in order to balance the baseline characteristics of the patients.The instruments used during the operations included a 5-mm rigid 30 camera, straight graspers (ethicon endosurgery, inc., cincinnati, oh, usa), and laparoscopic energy devices such as enseal g2 tissue sealertm (ethicon, inc., somerville, nj, usa) and caimantm (aesculap ag, inc., tuttlingen, germany).Reported surgical complication was of one of the patients who underwent vnotes (n=1), a small bowel thermal injury occurred from a laparoscopic energy device.In conclusion, the vnotes group demonstrated a low postoperative pain score within 12h after surgery.They also required less use of analgesic medications postoperatively.Other surgical outcomes were comparable between the two groups.This study showed that vnotes adnexectomy has comparable surgical outcomes to spa.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17256165
• MDR Text Key: 318577530
• Report Number: 3005075853-2023-04590
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NSEALXXX
• Was Device Available for Evaluation?: 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