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

Catalog Number ATS45

Device Problems Failure to Advance (2524); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t5ak4h.Device analysis: the analysis results found that the ats45 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 lockout.Firing through the lockout mechanism will break the device.Please reference the instruction for use for more information.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.

Event Description

It was reported that during a lap appendectomy, the ats45 was loaded with a white reload and handed to the doctor.He squeezed the closing trigger sufficiently to get the jaws through the trocar.The ats45 was placed across the base of the appendix.Closing trigger clicked closed and then he tried to close the firing trigger.It would not close.He released the gun on the tissue and then closed it again and then tried to fire but the knife would not advance.The ats45 was released from the tissue using the release button.Then an echelon 45 was opened to staple the appendix and the resulting staple line was over sewn.

• 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: 8776811
• MDR Text Key: 150747437
• Report Number: 3005075853-2019-20321
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001072
• UDI-Public: 10705036001072
• 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: 05/30/2019

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: 01/21/2024
• Device Catalogue Number: ATS45
• Device Lot Number: T92G4N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2019
• 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