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

Catalog Number	ECH45L
Medical Device Problem Codes	Component or Accessory Incompatibility (2897); Difficult to Open or Close (2921); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 7/11/2024.B3: exact event date unk, entered 1/1/2024 as only the year was provided.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.D4: batch # 590c26.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 an unknown trocar inserted in the device, with the anvil bent upwards and with the anvil knife slot damaged, and with an ecr45m reload loaded on the device.The reload was received fully fired.In addition, the jaws were partially open, the knife was noted to be partially deployed into the anvil.The device was closed and the bailout lever was moved up and the override lever was activated one time, and then, the jaw could be opened by pressing the release button.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.No functional test was performed due to the condition of the device.The device event log was reviewed and showed 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.It is possible that the knife was partially deployed may have been due to opening the jaws before the knife was fully returned home after firing.It is possible that the device was clamped over an excess of tissue causing the anvil to bend.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.Please reference the instruction for use for more information.Device history review: a manufacturing record evaluation was performed for the finished device batch number 590c26, and no non-conformances related to the reported complaint condition were identified.Additional information was requested and the following was obtained: 1.Was there any difficulty opening the device jaws? yes, attempted multiple times to open jaws.2.If yes, what steps were taken to open the jaws.Opening and closing handle over and over, jaws opened partially to remove from tissue.3.If the jaws could not be opened, how was the device removed.
Event or Problem Description
It was reported by the scrub tech first assist: during robotic case, ech45l was loaded and placed down trocar, opened, articulated and clamped on tissue.Firing sequence was completed, jaws were opened and removed off tissue.Cst-fa was unable to return anvil to home position in order to remove the device through trocar.Troubleshooting sequence followed, anvil still articulated.Trocar was completely removed to removed the stapler successfully.No harm to patient and procedure was completed successfully.I certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.

• 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: 19723630
• Report Number: 3005075853-2024-05039
• Device Sequence Number: 8290891
• Product Code: GDW
• UDI-Device Identifier: 10705036034964
• UDI-Public: 10705036034964
• 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): 07/11/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: ECH45L
• Device Lot Number: 590C26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown