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

Catalog Number	NSEALX22L
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # r9221y.Investigation summary: the device was received with the upper distal rollers missing not returned.In addition the blade was slightly buckled.This caused the upper jaw to not close completely.The device was connected to the generator and it was recognized.Because the jaw was loose not all testing was performed with the generator.The condition of the upper jaw prevented the functionality of the device.The jaw was unable to fully close.There is insufficient evidence related to what caused the damage.No conclusion could be reached as to what caused this issue.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 during the limb salvage procedure, the clamp jaws did not lock and it did not close.No patient consequence reported.

• Brand Name: ENSEAL G2 SUPER JAW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8119382
• Report Number: 3005075853-2018-14682
• Device Sequence Number: 1669945
• Product Code: GEI
• UDI-Device Identifier: 10705036013808
• UDI-Public: 10705036013808
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 11/19/2018

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: No Information
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: NSEALX22L
• Device Lot Number: R92807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 11/30/2018
• Patient Sequence Number: 1