MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 CURVED JAW 14CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSLG2C14
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch# r92n0p.Investigation summary : the device was received the upper jaw broken 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.However, due to the damaged at the jaw it is possible that this could have caused the reported issues.The condition of the jaws prevented the functionality of the jaw.The device was unable to cycle open and close.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.The batch history record was reviewed, and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
It was reported that the doctor had just started an open tah.The staff connected the device to the generator as usual.Once the case officially started and the surgeon was about to use the enseal and the device would not clamp properly on tissue and the energy was working.There were no patient consequences reported and the procedure was completed with an alternate like device.

• Brand Name: ENSEAL G2 CURVED JAW 14CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8007356
• Report Number: 3005075853-2018-13965
• Device Sequence Number: 16185359
• Product Code: GEI
• UDI-Device Identifier: 10705036014164
• UDI-Public: 10705036014164
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K112033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2018

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: 03/31/2023
• Device Catalogue Number: NSLG2C14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 10/25/2018
• Patient Sequence Number: 1