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

Model Number	ATS45NK
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # p56x3v.Investigation summary: the analysis results found that the ats45nk device (b) was received with the firing mechanism damaged and with three tr45w loads received.The reloads (c, d & e) were received partially fired 1/10 and the reload (d) with the reload lock out spring damaged.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 was found broken.As part of our quality process, the manufacturing records of this batch was reviewed, and the manufacturing standards were met prior to the release of this batch.The damage to the reload lockout spring is consistent with damage observed when the firing cycle is started, interrupted, released, and restarted.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.It should be noted that as part of our quality process, each device is visually inspected, and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.Reload c: tr45w p55806 partially fired 1/10; reload d: tr45w p55806 partially fired 1/10, spring damaged; reload e: tr45w, p5570g partially fired 1/10.
Event or Problem Description
It was reported that during the distal radical gastrectomy for gastric cancer surgery, could not fire when severing small intestine tissue on the 1st firing.Changed another ats45nk and tr45w to continue the surgery, the same problem happened again.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: 10719024
• Report Number: 3005075853-2020-05478
• Device Sequence Number: 3060345
• Product Code: GDW
• UDI-Device Identifier: 10705036001089
• UDI-Public: 10705036001089
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020779
• 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): 10/21/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2022
• Device Model Number: ATS45NK
• Device Catalogue Number: ATS45NK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 10/22/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TR45W X2