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

Catalog Number	NSLG2S45
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #r9412r.Investigation summary: the device was received the upper jaw damaged at the proximal side.The device was connected to the generator and it was recognized.Because the jaw was damaged not all functional testing could be performed with the generator.The condition of the jaws prevented the functionality of the jaw.The device was unable to cycle open and close.Therefore we were unable to investigate further the reported alert screen.A probable cause of the damage to the jaw 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 during unknown procedure they are receiving the error code multiple times and they are switching them out.Ensealg2.Case completed with another device of the same product code.There were no patient consequences reported.

• Brand Name: ENSEAL G2 STRAIGHT JAW 45CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8352302
• Report Number: 3005075853-2019-16711
• Device Sequence Number: 16693791
• Product Code: GEI
• UDI-Device Identifier: 10705036014195
• UDI-Public: 10705036014195
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/11/2019

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: 07/31/2023
• Device Catalogue Number: NSLG2S45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 02/19/2019
• Patient Sequence Number: 1