MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON 3000 45MM LONG; STAPLE, IMPLANTABLE

Catalog Number	ECH45L
Medical Device Problem Codes	Unintended Ejection (1234); Material Integrity Problem (2978); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/6/24.D4: batch # unk.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 #ech45l, with lot/batch #a9dr20, and no non-conformances 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 or Problem Description
It was reported that during an anterior resection procedure at the second firing transecting lower rectum in pelvis, a gst45b reload was used.Surgeon waited 15 seconds after closure before firing for tissue compression.Motor slowed to a stop due to thick tissue, pulse firing was used to complete the transection and knife blade returned.No obvious issue with staple line.Stapler was reloaded with cartridge for subsequent firing but during placement on rectum, cartridge fell out of stapler.Stapler and cartridge were removed, nurse noticed stapler anvil was slightly bent.New stapler and cartridge were opened to complete transection.Cdh29p was subsequently used to complete anastomosis, visual inspection by endoscope of staple line was good, air leak test was negative.The surgery was completed successfully with a delay of five minutes.There was no patient consequence.No additional information provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 04/17/2025.D4: batch #564c70 h4: corrected.Investigation summary: visual analysis of the returned sample determined that one ech45l device was returned with the anvil bent upwards and without 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.It is possible that the device was clamped over an excess of tissue causing the anvil to bend and for the firing stroke and the staple form to be incomplete.Please reference the instruction for use for more information.The event described of cartridge retention could not be confirmed as the reload was loaded into the device without difficulties and did not fall out during the visual and functional testing.The device event log was reviewed.The log indicates that the device had a high force to fire for one of the clinical firings, indicating that the device was firing over an obstruction, or too thick of tissue.In addition, he log indicates that articulation was attempted while the device was closed.Articulation function is blocked when the device is closed to prevent inadvertent patient injury.When the home button is pressed while the jaws are closed the device will attempt to retract the knife.When any of the other articulation buttons are pressed while the jaws are closed the device will provide haptic feedback indicating that articulation function is blocked.A manufacturing record evaluation was performed for the finished device batch 564c70, and no non-conformances were identified.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.

• Brand Name: ECHELON 3000 45MM LONG
• 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 00969 ; 3035526892
• MDR Report Key: 20864843
• Report Number: 3005075853-2024-09232
• Device Sequence Number: 20955092
• Product Code: GDW
• UDI-Device Identifier: 10705036034964
• UDI-Public: (01)10705036034964(10)A9DR20(17)260731
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K213633
• 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): 12/06/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: ECH45L
• Device Lot Number: A9DR20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male