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

Catalog Number ATS45

Device Problems Failure to Form Staple (2579); Failure to Cut (2587); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 1/9/2024.D4: batch # unk.B3: date of event is 2023, event day and month unknown.Captured as (b)(6) 2024.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Did the device deliver any staples? if yes, were the staples formed properly? if yes, was the staple line complete? did the device cut? if yes, was the cut line complete? if yes, was there any issue with the cut line such as jagged, dull knife, irregular, etc? was the device locked on tissue with the jaws closed? if yes, how was the device removed? what troubleshooting steps were attempted to open the device (e.G.Squeezing the closing trigger while simultaneously depressing the anvil release button, knife reverse switch, manual override)? did the jaws eventually open? a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 Description

It was reported that the device was stuck when trying to reopen and the staples did not form but it did not cut properly during a vankers procedure.They used a new device to complete case with no patient harm.

Manufacturer Narrative

(b)(4).Date sent: 2/5/2024.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 ats45 device was returned with no apparent damage and with no reload present on the device.The device was tested for functionality with a test reload and it fired, cut, and formed the staples as intended.The staple line and cut line were complete and the staples meet the staple form release criteria.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do 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.In addition, it notes that once the firing cycle has initiated, it must be completed.If re-initiation of firing is resumed after the instrument is unclamped, the instrument will lock out.If resistance is felt, stop and replace the reload.Ensure that the tissue lies flat and is positioned properly between the jaws.Any ¿bunching¿ of tissue along the reload, particularly in the crotch of the jaws, may result in an incomplete staple line the event described could not be confirmed as the device performed without any difficulties noted and no cartridge was returned for analysis.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number 643c68, and no non-conformances were identified.

• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18475693
• MDR Text Key: 332996031
• Report Number: 3005075853-2024-00188
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001072
• UDI-Public: 10705036001072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ATS45
• Device Lot Number: 500C64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• 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