MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS FLEX ARTICNG LNR CUTR 45MM; STAPLE, IMPLANTABLE

Catalog Number ATS45

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Only year (2017) is known.Device evaluation: the analysis results found that the ats45 device was received with no apparent damaged and with two reloads present not loaded on the device.Cartridge b, (b)(4), partially fired 1/10, lockout normal.Cartridge c, (b)(4), partially fired 1/10, lockout normal.This 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 lockout.Firing through the lockout mechanism will break the device.Please reference the instruction for use for more information.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 batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during an unknown procedure the stapler presented a defect at the moment of firing the loads - white and blue.It occurred twice with two charges.It was necessary to replace the loads.There were no patient consequences reported.

• Brand Name: ETS FLEX ARTICNG LNR CUTR 45MM
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7040182
• MDR Text Key: 93060455
• Report Number: 3005075853-2017-06164
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2021
• Device Catalogue Number: ATS45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1