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

Catalog Number ECH60L

Device Problems Failure to Fire (2610); Component or Accessory Incompatibility (2897); Difficult to Open or Close (2921); Material Integrity Problem (2978)

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

Event Date 01/12/2024

Event Type  malfunction  

Event Description

It was reported that it fired well the first few times but afterwards it got stuck on fire, wouldn't fire/articulate anymore where they had to take the whole trocar out during a gastric sleeve.They got another one to complete the case without patient harm.

Manufacturer Narrative

(b)(4).Date sent: 4/26/2024 d4: batch # 597c89 additional information was requested, and the following was obtained: 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? they had to utilize the manual override but would not de articulate.Investigation summary the product was returned to ethicon endo-surgery for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that one ech60l device was returned with the anvil bent upwards and with a gst60b reload present.The reload was received fully fired.The manual override door out of position; the override lever was up which denotes that the knife was manually returned to home position.It should be noted after the manual override system is used the instrument is disabled and cannot be articulated or used for any subsequent firings.As additional testing, the bailout system was reset and then, it was tested for functionality in the straight position with a test reload and achieved its complete firing sequence.The staple line and cut line were complete and the staples meet the staple release criteria.The device opened and closed without any difficulties noted.No issue related to instrument compatibility was noted.After further analysis, the articulation mechanism was not working properly, and the lower right articulation button was hard to press.The device was disassembled to verify the internal components and the conformal coating on the top right sensor of the pcb board was found indented, indicating interference between the sensor and the shroud, this condition can make it difficult to fully depress the buttons.In addition, one of the articulation laminates was bent, it is possible that the damaged laminate was caused due to an external force applied to the jaws, forcing them to articulate.It is possible that the device was clamped over an excess of tissue causing the anvil to bend.Please reference the instruction for use for more information.The damage to the pcb board is potentially related to a manufacturing process.This product issue will be addressed through ethicon endo surgery¿s quality system.A manufacturing record evaluation was performed for the finished device batch number 597c89, and no non-conformances were identified.

• Brand Name: ECHELON 3000 60MM LONG
• 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 ; *
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 19197278
• MDR Text Key: 341581742
• Report Number: 3005075853-2024-03275
• 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
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECH60L
• Device Lot Number: 597C89
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2023
• 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