MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 STRAIGHT JAW 25CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSLG2S25
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # t92g64.Investigation summary: the device was received with the shaft damage.The device was connected to the generator but due to the condition of device not all functional testing could be performed.Due to the damage at the shaft the device could not be opened as the i-blade did not move back or forward.This resulted in the reported issues.No conclusion could be reached how the shaft got damage.Additionally as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.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 an exploratory laparotomy the on the first attempt at using the device the jaws would not close.The procedure was completed with an alternate like device with no patient consequences reported.

• Brand Name: ENSEAL G2 STRAIGHT JAW 25CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8853338
• Report Number: 3005075853-2019-20965
• Device Sequence Number: 18911867
• Product Code: GEI
• UDI-Device Identifier: 10705036014126
• UDI-Public: 10705036014126
• 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): 07/09/2019

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: 01/31/2024
• Device Catalogue Number: NSLG2S25
• Device Lot Number: T92J6E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 08/01/2019
• Patient Sequence Number: 1