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 Problems Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Title: feasibility and safety of total laparoscopic retrograde hysterectomy in a large uterus with obliterated cul-de-sac due to severe endometriosis authors: megumi yamamoto a,b, hiroshi yoshida a,c,* citation: european journal of obstetrics & gynecology and reproductive biology (2021); 258:43¿47.Https://doi.Org/10.1016/j.Ejogrb.2020.12.042.The aim of this single-institute, retrospective, case-control, observational study is to examine the safety and feasibility of total laparoscopic retrograde hysterectomy (tlreh) in patients with obliterated cul-de-sac due to severe endometriosis, including patients with a large uterus.Between january 2014 and december 2019, a total of 92 women (mean age of 46.0 ± 4.8 years; mean bmi of 22.2 [17.0¿42.0] kg/m2) with obliterated cul-de-sac due to severe endometriosis who underwent tlreh were included.The energy device used was the enseal (johnson and johnson k.K.Medical company, tokyo, japan).Reported complications include unknown event requiring blood transfusion (n=1) and bladder injury (n=1).In conclusion, the study demonstrated that tlreh for severe endometriosis with obliterated cul-de-sac was feasible and safe.It could be safely performed for large uteri (=600 g) with obliterated cul-de-sac due to severe endometriosis.

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.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 further information will be provided because we can¿t get any additional information from the author.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: 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: 15563317
• MDR Text Key: 301360677
• Report Number: 3005075853-2022-06304
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• 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: 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
• Patient Sex: Female