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

Catalog Number	ECH45L
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a wedge resection, the surgeon had issues clamping down but was able too.Three times they experienced a lock out.Case was completed with a like device.No patient harm was reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/24/2024.D4: batch # 774c58.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.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 ech45l device was returned with the anvil bent upwards, with a dent in the nozzle, and no reload present.During analysis, it was observed that the distal crimp ring is missing and thus not retaining the joint cover.As additional testing, the device was dry fire and the device did not work properly.In order to verify the condition of the internal components, the joint cover was removed and it is observed a crack through the channel side of the closure ring, making the device not work properly, since this condition allowed the device to fire without a reload loaded.No functional test could be performed due to the condition of the device.The damage to the nozzle is potentially related to a manufacturing process.The damage to the device is consistent with the device being clamped over an excess of tissue.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 closure ring 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 774c58, and no non-conformances related to the reported complaint condition were identified.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.Clarification on what is meant by "lock out".Was there difficulty opening the device? was there difficulty firing the device? 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 ; * 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: 19821911
• Report Number: 3005075853-2024-05387
• Device Sequence Number: 20999187
• 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): 07/24/2024

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: 774C58
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GST45T
• Patient Sex: Unknown