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

Catalog Number	6TB45
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch number: n54h01.Investigation summary: the analysis results found that the 6tb45 device was received with no apparent damaged and with a tr45w cartridge loaded on the device.The returned reload was partially fired 1/10.The returned device was tested for functionality with a test reload and it fired, cut, and all the staples formed as intended.The device fired without any difficulties, the staple line was complete and the staples were noted to have the proper b-formed shape.The condition of the reload indicates that the device's firing cycle was interrupted.When firing the device make sure that the firing stroke is completed.Do not partially fire the device.Fire the device by squeezing the firing trigger completely until it rests on the closing trigger.Once the firing cycle has been initiated, it must be completed.If re-initiation of firing is resumed, the device will lock out.Firing through the lockout mechanism will break the device.Please reference the instruction for use for more information.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 the device could not fire.During the radical resection of rectal cancer, could not fire.Another device was used to complete the surgery.There were no adverse consequences to the patient.

• Brand Name: 45MM ARTICNG LNR CUTR/6 ROW BL
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7641456
• Report Number: 3005075853-2018-10951
• Device Sequence Number: 1556229
• Product Code: GDW
• UDI-Device Identifier: 20705036000874
• UDI-Public: 20705036000874
• Combination Product (Y/N): N
• PMA/510(K) Number: K070887
• 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): 06/07/2018

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: 03/22/2021
• Device Catalogue Number: 6TB45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1