MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 ART CURV SEALER 45CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	NSLG2C45A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a robotic assisted prostatectomy procedure that the device locked on tissue.Device was eventually removed from tissue.How the device was removed was not specified.Another like device was used to continue with the procedure.There were no adverse consequences for the patient.
Additional Manufacturer Narrative
(b)(4).Batch #: x95p7a.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/17/2023.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 revealed that 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 the tissue impedance threshold is reached and tone 3 is heard when the cycle is complete).No issues were noted with opening and closing of the jaws.There were no anomalies noted with the functionality of the device.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event.The event described could not be confirmed as the device performed without any difficulties noted.No product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.

• Brand Name: ENSEAL G2 ART CURV SEALER 45CM
• Common Device Name: 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: 16086808
• Report Number: 3005075853-2023-00007
• Device Sequence Number: 6640024
• Product Code: GEI
• UDI-Device Identifier: 10705036014553
• UDI-Public: 10705036014553
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NSLG2C45A
• Device Catalogue Number: NSLG2C45A
• Device Lot Number: X95P7A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 01/02/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Patient Sex: Unknown