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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # m93e3u.Event date is unknown.Investigation summary : the device was returned with the lower jaw damaged.Testing found a short on the device when the jaws are fully closed, resulting in an alert screen "reposition jaws and reactive", this is advising that the instrument is being activated on low impedance (thin) tissue or metal (such as staples, clips, retractors, or clamps), the "replace instrument" alert screen would be displayed after receiving the "reposition and reactivate" alert screen twice.A probable cause of the damage to the jaws 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 device was received with no complaint information.Attempts were made to reconcile the device with no success resulting in the creation of a new complaint.

• 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: 7895989
• Report Number: 3005075853-2018-12918
• Device Sequence Number: 1395037
• Product Code: GEI
• UDI-Device Identifier: 10705036014164
• UDI-Public: 10705036014164
• 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): 09/19/2018

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: 10/30/2020
• Device Catalogue Number: NSLG2C14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 09/20/2018
• Patient Sequence Number: 1