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 Fistula (1862)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Publication year of 2020.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: multi- and single-port laparoscopic surgery in the treatment of hydatid liver disease authors: s.V.Minaev, i.N.Gerasimenko, i.V.Kirgizov, a.N.Grigorova, m.F.Rubanova citation: pirogov journal of surgery (2020);4:37-41.Https://doi.Org/10.17116/hirurgia202004137 the objective of this study consisted of comparing multi- and single-port laparoscopy during the treatment of hydatid liver disease.A total of 25 children (17 boys and 8 girls; mean age of 10.1±2.05 years) with solitary hydatid cyst of the liver (cl-ce2) underwent surgery in 2013 to 2017.These patients were divided into 2 groups: group 1 (multi-port laparoscopic hydatidectomy) included 19 children using manipulation ports (5, 10, or 12 mm endopath xcel, johnson & johnson, usa), while group 2 (single-port laparoscopic hydatidectomy [single-incision laparoscopic surgery ¿ sils] included 6 patients using a competitor device.Using a g11 ultrasound generator and enseal artificial bipolar coagulation (johnson & johnson, usa), the cyst was opened and the altered fibrous liver tissue with a ¿thinned¿ parenchyma was removed.Reported complications include mild pain syndrome (n=?) which only required pain relief for the first few days; and biliary fistula (n=1) which was treated conservatively by means of external drainage.In conclusion, the presence of unicameral hepatic hydatid cysts among children in the stage ranging from cl to ce2 is an indication for the performance of a laparoscopic hydatidectomy.Multi-port laparoscopy has advantages over the single-port version, being a safer treatment technique that ensures a decrease in surgery time and the incidence of postoperative complications.

Manufacturer Narrative

(b)(4).Date sent: 12/2/2021 upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 12744067
• MDR Text Key: 279796232
• Report Number: 3005075853-2021-06624
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K072177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention