MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON 3000 60MM LONG; STAPLE, IMPLANTABLE

Catalog Number ECH60L

Device Problems Material Separation (1562); Use of Device Problem (1670); Failure to Fire (2610); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 8/15/2023.D4: batch # unk.B3: exact event date unk, entered (b)(6)2023 as only the year was provided.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.A manufacturing record evaluation was performed for the finished device lot/batch number, a9c65y, and no non-conformances were identified.Additional information was requested and the following was obtained: please confirm when the stapler closed and a loud crack was heard was the device on tissue or was nothing between the jaws? there was nothing in between the tissue.Did the difficulty to close happen before or after firing the device? before firing the device.Are any pictures available for review? no.What color cartridge was being used? black.Was any external damage observed on the device? no.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.Please provide timeline of events? was the use of the device any way related to the perforation of the lung? 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 during a vats procedure, the lung was perforated and had to convert to an open procedure for a wedge resection.On the third firing on the lung he went to articulate the device, while doing so the black plastic articulation joint opened and metal was exposed.The provider then went to close the stapler and was unable to do so.The provider pulled the stapler out of the patient and it took all of the force they had to close the jaws.When doing this it caused for a loud crack to come from the stapler.Still outside of the patient the provider tried to fire the stapler and the stapler would not fire.They opened a new device to complete the case.There was a delay in the procedure.No patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent: 10/6/2023.D4: batch # 368c91.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 one ech60l device was returned with the joint cover damaged, with the jaws and trigger in the close position.Also, the knife was noted as partially advanced, the home button was pressed to return the knife to the home position and the knife returned to the home position as expected and with no reload present.The device was tested for functionality in the straight position with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples meet the staple release criteria.Also, no abnormal noises were noted during functional testing.The event described could not be confirmed as the device performed without any difficulties noted.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.The damage on the joint cover, it is possible that the device was attended to be pulled out from a trocar in the articulated position, resulting in the edge of the trocar damaging the joint cover.Please reference the instruction for use for more information.Device history review: a manufacturing record evaluation was performed for the finished device batch number 368c91, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 10/17/2023.Additional information was requested and the following was obtained: was the use of the device any way related to the perforation of the lung? no.Upon review of the additional information provided, it was concluded that this event does not meet the fda defined criteria for a serious injury and is being considered a malfunction.

• Brand Name: ECHELON 3000 60MM LONG
• 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: 17552196
• MDR Text Key: 321223478
• Report Number: 3005075853-2023-05812
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036034988
• UDI-Public: 10705036034988
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213633
• 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,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECH60L
• Device Lot Number: LOT #A9CV16; BATCH # 368C91
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention