MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS ARTIC LNR CUTR NO KNIFE; STAPLE, IMPLANTABLE

Model Number	ATS45NK
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u5d75g.(b)(4).Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the ats45nk device was received with the firing trigger broken and with a tr45w reload loaded on the device.The returned reload was partially fired 1/2.No functional test could be performed due to the condition of the device.No conclusion could be reach on what caused firing trigger broke a manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.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 the 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.Although no conclusion could be reach on the cause of the damage in the firing trigger, the instructions for use contain the following caution: attempting to force the trigger to complete the firing stroke with too much tissue between the jaws, or with dense/thick tissue between the jaws, may result in instrument failure.
Event or Problem Description
It was reported that during radical gastrectomy for gastric cancer surgery, could not fire when severing jejunal tissue.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.

• Brand Name: ETS ARTIC LNR CUTR NO KNIFE
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 12245851
• Report Number: 3005075853-2021-04238
• Device Sequence Number: 11541349
• Product Code: GDW
• UDI-Device Identifier: 10705036001089
• UDI-Public: 10705036001089
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2021

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: 06/18/2025
• Device Model Number: ATS45NK
• Device Catalogue Number: ATS45NK
• Device Lot Number: U94P7W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/29/2021
• Patient Sequence Number: 1