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

Model Number	NSLG2C45
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # t94e62.Investigation summary: the device was returned with the bottom portion of the i blade out of the lower jaw channel; the lower jaw channel was damaged.The device was connected to the generator and it was recognized.Because of the condition of the device not all functional testing could be performed with the generator.Therefore we were unable to investigate further the reported event.The jaw was unable to cycle open and close.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.
Event or Problem Description
It was reported that during a laparoscopic duodenal switch the device failed to activate/malfunctioned after initial use.A second device was opened and had the same issue.A third device was used to complete the case with no patient consequences.

• Brand Name: ENSEAL G2 CURVED JAW 45CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 9856952
• Report Number: 3005075853-2020-01716
• Device Sequence Number: 14310711
• Product Code: GEI
• UDI-Device Identifier: 10705036014157
• UDI-Public: 10705036014157
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 02/28/2020

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: 08/31/2024
• Device Model Number: NSLG2C45
• Device Catalogue Number: NSLG2C45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/19/2020
• Patient Sequence Number: 1