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

Model Number	NSLG2C14
Medical Device Problem Codes	Difficult to Open or Close (2921); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: t93r6v.Device analysis: the device was received with the top of the i-blade upper tip broken off not returned.In addition, no damaged at the jaws were observed as reported.The device was connected to the generator and it was recognized.Because the i blade was damaged not all functional testing could be performed with the generator.The condition of the blade prevented the functionality of the jaw.The jaw was unable to cycle open and close.A probable cause of the damage to the i blade could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.Photo analysis: the image provided by the customer is that of the distal jaw of what appears to be an nseal device.A closer look at the clamp arm interface shows that the iblade upper tip was broken off.A probable cause of the damage to the i blade could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.
Event or Problem Description
It was reported that the jaw of the device cannot be opened and closed properly during the surgery.It was observed the i-blade of the upper jaw and the hinge joint were damaged, therefore the jaw cannot be controlled by the handle normally.The surgery was completed by opening a new pack of the same device.There were no patient consequences.

• 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 ; * 00969
• MDR Report Key: 10824457
• Report Number: 3005075853-2020-05913
• Device Sequence Number: 11517161
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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: 05/31/2025
• Device Model Number: NSLG2C14
• Device Catalogue Number: NSLG2C14
• Device Lot Number: T93R6V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/11/2020
• Patient Sequence Number: 1