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	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # t9522f.Investigation summary: the device was received with the i-blade damage.During the mechanical test, the device was difficult to open and close.However, the damage was not enough to prevent the device to open and close fully.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).A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.A probable cause of the damage to the i-blade could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.
Event or Problem Description
It was reported that during an unknown procedure, the device handle was not closing properly.It was sticking and requiring too much force to fire.The case was completed with a new device.There were no patient consequences.

• 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: 9829332
• Report Number: 3005075853-2020-01562
• Device Sequence Number: 19002642
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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: 10/31/2024
• Device Model Number: NSLG2C45A
• Device Catalogue Number: NSLG2C45A
• Device Lot Number: T95720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/13/2020
• Patient Sequence Number: 1