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

Catalog Number	ECH45L
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 9/11/2024.D4: batch #941c81.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 ech45l device was returned with the anvil bent upwards and with a gst45w reload loaded on the device.The reload was received fully fired.Furthermore, the anvil knife slot was noted to be damaged.No functional test was performed due to the condition of the device.Additionally, photos were provided and they showed the condition of the reported event.The event log was reviewed.An event was found that typically indicates that the knife encountered the firing safety lockout mechanism.This mechanism ensures that the knife cannot deploy without an unfired reload installed.It is possible that it occurred due to improper installation of the reload.Always ensure that the retaining cap is in place when a reload is installed into a device.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.It is possible that the combination of tissue and/or buttressing material compressed between the device jaws may have been beyond indicated thickness or tissue that cannot compress to the indicated range for the selected reload.This may have caused excessive force to be applied to the underside of the solid steel anvil leading to this damage.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.A manufacturing record evaluation was performed for the finished device batch number 941c81, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure; customer closed down on tissue, waited 15 seconds and fired device.Tissue was stapled and transected.As device was returning to the home position they heard a popping sound.Device was opened and removed from tissue.As cst was trying to remove device from abdomen they could not close device.After multiple attempts he was finally able to close.There was no patient consequences reported.Unknown surgical delay.

• Brand Name: ECHELON 3000 45MM LONG
• Common Device Name: 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; guaynabo ; * ; 3035526892
• MDR Report Key: 20190651
• Report Number: 3005075853-2024-06777
• Device Sequence Number: 7112738
• Product Code: GDW
• UDI-Device Identifier: 10705036034964
• UDI-Public: (01)10705036034964(17)270331(10)941C81
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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 Catalogue Number: ECH45L
• Device Lot Number: 941C81
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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: Unknown