MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 45MM ARTICNG LNR CUTR/6 ROW BL; LINEAR CUTTER

Catalog Number	6TB45
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # n54h01.Device evaluation: the analysis results found that the 6tb45 device was received with the firing mechanism damaged and with 6r45b cartridge loaded in the device.The reload was fully fired and with the lockout spring normal.No functional test could be performed due to the condition of the device; however, the device closed and opened properly during testing.The device was disassembled to verify the condition of the internal components and the firing trigger teeth were found broken.No conclusion could be reached on what caused the firing mechanism to fail, it is possible that the device was attempted to fire on thicker tissue than indicated or attempted to fire through a locked reload in previous firings causing an increase of the internal forces resulting in the component yielding.It should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the require specifications; in addition, a sample of the batch is inspected at fgqa.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
It was reported that during the laparoscopic anterior resection of rectum, after fired, could not open the jaw.Opened the jaw manually with big force.There were no adverse consequences to the patient.

• Brand Name: 45MM ARTICNG LNR CUTR/6 ROW BL
• Common Device Name: LINEAR CUTTER
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7227282
• Report Number: 3005075853-2018-07593
• Device Sequence Number: 13796055
• Product Code: GDW
• UDI-Device Identifier: 20705036000874
• UDI-Public: 20705036000874
• Combination Product (Y/N): N
• 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): 12/28/2017

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: 03/22/2021
• Device Catalogue Number: 6TB45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1