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	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # r92c97.The batch history records were reviewed and the manufacturing criteria were met prior to the release of this batch.
Event or Problem Description
It was reported that at the beginning of an abdominal total hysterectomy, when using for the first time, when closing on tissue it broke at the height of the jaw, resulting in the loss of the loose piece.The necessary measures were taken to verify that said part of the instrument was not lodged in the patient's cavity.After radiological study it is confirmed that the piece did not affect the patient or the user in any way.

• 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: 7975673
• Report Number: 3005075853-2018-13675
• Device Sequence Number: 1131799
• Product Code: GEI
• UDI-Device Identifier: 10705036014164
• UDI-Public: 10705036014164
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K112033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2018

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: 01/31/2023
• Device Catalogue Number: NSLG2C14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/17/2018
• Patient Sequence Number: 1