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

Catalog Number	NSLG2S25
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that during a whipple procedure the surgeon was using the device to dissect tissue when the tip broke off.The tip was retrieved and taken out of the sterile field along with the device.A second like device was used to complete the procedure 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: 7265152
• Report Number: 3005075853-2018-07932
• Device Sequence Number: 13909088
• Product Code: GEI
• UDI-Device Identifier: 20705036014123
• UDI-Public: 20705036014123
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2018

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: 01/31/2022
• Device Catalogue Number: NSLG2S25
• Device Lot Number: P91J39
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1