MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 ART CURV SEALER 35CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number NSLG2C35A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 04/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # p93d36.Investigation summary: the device was received with no apparent damage.The device was tested on the generator and passed all functional testing.The energy output delivered from the device was verified.All three tones were heard during functional testing (tone 1 is heard when the energy activation button is pressed; tone 2 is heard when tissue impedance threshold is reached and tone 3 is heard when the cycle is complete).The device was tested with the test media and no anomalies were found.There were no anomalies noted with the functionality of the device.The batch history record was reviewed and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process information requested but unavailable: does the surgeon believe the bleeding of the upper gastric artery is an alleged deficiency of the device? what does the surgeon believe is the root cause of the upper gastric bleed?.

Event Description

It was reported that during a laparoscopic left oophorectomy procedure upon removal of the ovary it was noticed that there was excess bleeding from the epi-gastric artery.They tried to stop the bleeding laparoscopically with the device and then with a bovie device.This did not work.They converted to open due to being unable to stop the bleeding at various sites.Performed ligation of the left epi-gastric repair with suture to stop the bleeding.The patient is in stable condition.

• Brand Name: ENSEAL G2 ART CURV SEALER 35CM
• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7474539
• MDR Text Key: 106959451
• Report Number: 3005075853-2018-09458
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20705036014505
• UDI-Public: 20705036014505
• Combination Product (y/n): N
• PMA/PMN Number: K122797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 04/10/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: NSLG2C35A
• Device Lot Number: P93G5J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention