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

Catalog Number	ECH45S
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Fire (2610); Difficult to Open or Close (2921); No Apparent Adverse Event (3189); Noise, Audible (3273)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 6/23/2026 d4: batch #unk d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.H4: the device manufacture date is currently not available.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: please clarify "result left a hole." is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event? did the device staple? if yes, was the staple line complete (full length)? was the device locked on tissue with the jaws closed? if yes, what steps were taken to open the jaws? (pull open the closing trigger, press home button, use bailout) if the home button was pressed, did the knife fully return to its home position? if the jaws could not be opened, how was the device removed? the device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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 unknown procedure of the liver, surgeon went to use echelon 3000 stapler and the battery died - did not have enough power to fire through entire organ (liver) and as a result left a hole.Rep was on site in the days following and spoke with surgeon - the surgeon said the battery did not sound right - not a slowing down in thick tissue but a very sluggish sound and then died.Surgeon was firing on a vessel in the liver and was very anxious about the outcome - used the manual override to reverse it.Resident told me separately but did not form properly.Surgeon opened a new stapler and completed the procedure.There was no patient consequence reported.No additional information provided.

• Brand Name: ECHELON
• 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: orla o'mahony ; 475 calle c; guaynabo 00969 ; 3035526892
• MDR Report Key: 25595609
• Report Number: 3005075853-2026-04858
• Device Sequence Number: 14798051
• Product Code: GAG
• UDI-Device Identifier: 10705036035008
• UDI-Public: (01)10705036035008(17)290131(10)A99J66
• 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): 06/29/2026

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: ECH45S
• Device Lot Number: A99J66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2026
• 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