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

Model Number ATS45

Device Problems Crack (1135); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t5cg6m.Device analysis: the analysis results found that the ats45 device was received with the firing mechanism damaged and with no cartridge loaded in the device.No functional test could be performed due to the condition of the device.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% inspection takes place during manufacturing to ensure the device meets the require specifications.In addition, a sample of the batch is inspected at fgqa.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.Additional information was requested, and the following was obtained: did the device lock-out (no staples deployed and no cut line started)? no cut line was started, device was closed, when he wanted to fire, was cracking sounds and device stopped.Or, did the device partially fire (start to deploy staples and cut but could not be completed)? device did not cut, but few staples were out.Did the device deliver any staples? yes but surgeon couldn`t reply was staples formed in b shape if yes, were the staples formed in the proper closed b-formation? yes but surgeon couldn`t reply was staples formed in b shape if the stapler did fire was the staple line complete? no staple line was not complete was the device locked on tissue with the jaws closed? yes device stocked with closed jaws if yes, how was the device removed from the patient (i.E.Anvil release button, jaws forced open, cut from tissue, etc.)? it was really hard to get device open, hard movement was needed to open it.There was no cutted tissue if yes, did the jaws eventually open? surgeon removed tissue from jaws when device was open, it was not cutted tissue inside, just compressed, than before remove device form patient through trocar, they closed the device.

Event Description

It was reported that during an unknown procedure, when the surgeon was closing the device, he heard strange sounds like smith cracking in handle.Device was closed but cut till half.Surgeon couldn¿t return a knife.Procedure was finished with another device.It is unknown if the surgery was delayed but the surgery was completed successfully.There were no patient consequences.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9769623
• MDR Text Key: 201705504
• Report Number: 3005075853-2020-01318
• 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: 01/15/2020

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: 04/16/2024
• Device Model Number: ATS45
• Device Catalogue Number: ATS45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1