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

Model Number	NSLG2C45A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # t94g7t.Device analysis: the device was received with the lower jaw bent.Upon inspection under magnification of the jaw it was noted that electrode was slightly separated from the lower jaw.This resulted in a short and a ¿reposition jaws and reactivate¿ alert screen when the jaws were fully or partially closed.Due to the condition of the device not all functional testing could be performed.The "replace instrument" alert screen would be displayed after receiving the "reposition and reactivate" alert screen three time.The ptc was damaged due to the short.A probable cause of the damage to the retention pins could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that before a robot-assisted unknown procedure, the gaze was stuck between the jaws.When the sales rep and medical engineer checked the device and returned the handle to the home position, the gaze came out.Gen11 was used.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• 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 ; * 00969
• MDR Report Key: 9731880
• Report Number: 3005075853-2020-01133
• Device Sequence Number: 765251
• Product Code: GEI
• UDI-Device Identifier: 10705036014553
• UDI-Public: 10705036014553
• Combination Product (Y/N): N
• PMA/510(K) Number: K112033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/10/2019

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 Expiration Date: 08/31/2024
• Device Model Number: NSLG2C45A
• Device Catalogue Number: NSLG2C45A
• Device Lot Number: T94L01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/20/2020
• Patient Sequence Number: 1