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 Hemorrhage/Bleeding (1888)

Event Date 02/22/2021

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 devices endopath*5mm grasper and enseal 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: hysterectomy and adnexal procedures by vaginal natural orifice transluminal.Endoscopic surgery (vnh): initial findings from a korean surgeon.Author: myeong-seon kim, joseph j.Noh and tae-joong kim.Citation: kim m-s, noh jj and kim t-j (2021) hysterectomy and adnexal procedures by vaginal natural orifice.Transluminal endoscopic surgery (vnh): initial findings from a korean surgeon.Front.Med.7:583147.Doi: 10.3389/fmed.2020.583147.The objective of this study is to evaluate feasibility and safety of hysterectomy and adnexal procedures by vaginal natural orifice transluminal endoscopic surgery (vnotes).From april 2018 to june 2019, a total of 34 female patients underwent vnotes using suction and irrigator, short grasper (endopath grasper 5mm, ethicon us, llc), and enseal g2 tissue sealer (45 cm length and curved tip, ethicon us, llc).One patient underwent transumbilical single-port surgery because of late-onset postoperative bleeding on the 13th postoperative day.Although there were three complications, vnotes offers advantages to patients and surgeons.More surgical techniques will be developed in vnotes.

• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15490806
• MDR Text Key: 300823754
• Report Number: 3005075853-2022-06435
• 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: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NSEALXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention