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

Catalog Number ATS45

Device Problems Structural Problem (2506); Failure to Fire (2610); Component or Accessory Incompatibility (2897)

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

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 2/7/2024.D4: batch # 398c46.Additional information was requested, and the following was obtained: 1.Could you please provide more details for "the stapler then jammed when released"? 2.Did the device lock out (no staples deployed and no cut line started)? ¿ exactly.And i think, that the firing handel was touched while the surgeon was trying to insert the ats45 through the 12mm trocar, which is too small.And after that the ats45 has activate the safety lock.3.Or, did the device start to deploy staples and cut but could not be completed (partially fire)? n/a.4.Or, did the device fully fire and stop during the automatic knife return? n/a 5.Was there any difficulty opening the device? - no.6.If yes, how was the device removed from the patient? n/a.7.If yes, did the jaws eventually open? n/a.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 determined that the ats45 device was received with no apparent damage and with a tr45w reload loaded in the device.The reload was received partially fired 1/10 and the reload lockout spring was damaged.The returned device was tested for functionality with test reload and it fired, cut, and formed all the staples as intended.The staple line and cut line were complete, and the staples meet the staple form release criteria.The device can be introduced/removed through the trocar.The event reported of would not fire and staple retaining cap issue was confirmed and it is related to improper use of the device.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 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.The instrument compatibility was noted as expected during the functional test.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 398c46, and no non-conformances were identified.

Event Description

It was reported that there was an attempt made to get the stapler into the situs using a 12.5 mm reusable trocar.This did not work, as such a trocar is too small.A 12 mm disposable trocar was then used, with which the insertion of the ats45 worked.When the ats45 was opened (in the situs), the first staples fell out of the magazine.The stapler then jammed when released.A new ats45 was opened, and the appendectomy was successfully completed.No patient harm nor significant delay reported.

• 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: kate karberg ; 475 calle c; raynham ; * ; 3035526892
• MDR Report Key: 18659396
• MDR Text Key: 334761507
• Report Number: 3005075853-2024-01085
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2024

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 Catalogue Number: ATS45
• Device Lot Number: A9DM4V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2023
• 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