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	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 7/11/2023.D4: batch # unk.A manufacturing record evaluation was performed for the finished device lot/batch number, x95h7n, and no non-conformances were identified.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that in the operation, after using the first firing and reload cartridge.And then next firing stage, it was not stapled.No patient consequences reported.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/23/2023.D4: batch # 827a48.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 mechanism damaged and no reload 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 pinion axel support was found damaged.Batch records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.No conclusion could be reached on what cause the firing mechanism to fail, it is possible that the device was attempted to fire on ticker tissue then indicated or attempted to fire trough a locked reload in previous firings causing an increase of the internal forces resulting in the component yielding.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Although there is no direct evidence of use error, the instructions for use do contain the following caution: when positioning the stapler on the application site, ensure that no obstructions such as clips, stents, guidewires, etc., are within the instrument jaws.Firing over an obstruction may result in improperly formed staples, and/or inability to open the instrument jaws.Incomplete firing may result in malformed staples, incomplete staple line, bleeding, and/or difficulty removing the device.A manufacturing record evaluation was performed for the finished device batch number 827a48, and no non-conformances were identified.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17297570
• Report Number: 3005075853-2023-04797
• Device Sequence Number: 12514875
• Product Code: GDW
• UDI-Device Identifier: 10705036001089
• UDI-Public: 10705036001089
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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 Model Number: ATS45NK
• Device Catalogue Number: ATS45NK
• Device Lot Number: X95H7N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown