MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC.; STAPLER, SURGICAL

Catalog Number	EC3D60L
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified surgical procedure, it was observed that the device was barely pulsing.Then towards the end it wasn't firing anymore and they had to force the jaws open to finish.There was no patient consequence nor surgical delay reported.No additional information provided.
Additional Manufacturer Narrative
(b)(4) date sent: 5/5/2026 d4: batch #unk.Additional information was requested, and the following was obtained: it was a white reload.It didnt even seem to reach the end of the firing.Orange was only visible on the deck 3/4th of the way through.The case was a lap conversion of sleeve gastrectomy to rny firing was one he has done 100s of times - white reload on the small bowel which he never has troubles with.He does not usually pulse on this fire.He mentioned it was pulsing and struggling to complete fire.Motor/battery issue maybe? the only issue in pulsing/firing was the 1st firing of the entire case.After incident, we opened a new stapler and it worked as intended for the remaining of the case.Jaws would not open.We followed odp.No luck.So, we manually brought knife back and discarded device.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.A manufacturing record evaluation was performed for the finished #ec3d60l, with lot/batch #a9944h, 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.

• Common Device Name: STAPLER, SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; 3035526892
• MDR Report Key: 25082365
• Report Number: 3005075853-2026-03377
• Device Sequence Number: 13405248
• Product Code: GAG
• UDI-Device Identifier: 10705036043546
• UDI-Public: (01)10705036043546(17)281031(10)A9944H
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 05/05/2026

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: EC3D60L
• Device Lot Number: A9944H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2025
• 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