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

Model Number NSLG2C35A

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 11/07/2022

Event Type  Injury  

Event Description

It was reported that during the tlh they were using the device and noticed some black stuff coming out of the end of the device and learned it was the insulation on the shaft.They had to open the patient because they had fibroids.The surgery was still happening at the time of call.

Manufacturer Narrative

(b)(4).Batch #: x95343.Additional information was requested and the following was obtained: procedure was converted to open due to fibroid size and not due to device failure.Per the initial device was removed due to the insulation coming off of the device near the articulation joint.Sales rep stated there were no adverse consequences reported for the patient.What is the surgeon¿s experience with the device?.Very experienced at what point in the surgery did they see the black insulation come off?.Unknown did they insert and remove the g2 device from the trocar often during the surgery?.Unknown.Was the person who provided this complaint in the procedure?.Yes but report went point person to where replacement product is someone else investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the device was received with skiving of the heat shrink (shaft cover) material not all present.The device was mechanically tested and no anomalies were noted.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 the tissue impedance threshold is reached and tone 3 is heard when the cycle is complete).The ifu warns "prior to inserting or removing the device from the trocar, ensure that the device is in the straight, non-articulated position by confirming that the indicator arrow on the articulation wheel is aligned with the top of the instrument." the ifu also warns the user to discontinue use if black heat shrink covering is damaged.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot/batch x95343, and no non-conformances were identified.

Manufacturer Narrative

Pc-(b)(4).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 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 15904659
• MDR Text Key: 304689324
• Report Number: 3005075853-2022-08295
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036014508
• UDI-Public: 10705036014508
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLG2C35A
• Device Catalogue Number: NSLG2C35A
• Device Lot Number: X95343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention