MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. N/A; STAPLE, IMPLANTABLE

Catalog Number	ECS29A
Medical Device Problem Codes	Structural Problem (2506); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 5/4/2026.D4: batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Additional information was requested and the following was obtained: 1.Please provide more details about the device quality issue.Difficult to remove the device after the fire.2.Did the device staple? yes 3.If yes, was the staple line complete (fully circular)? yes 4.Did the device have staple line issues? malforms, missing staples, no staples etc unknown 5.Was the breakaway washer completely cut? unknown 6.Were there two complete tissue donuts? yes 7.Was it a partial cut? no 9.Did the device cut the tissue? yes 10.Was the device locked on tissue with the anvil closed? yes 11.If yes, what steps were taken to open the anvil? unknown 12.If the anvil could not be opened, how was the device removed? unknown 13.Did the surgeon turn the rotation knob full revolutions as stated in the ifu? yes 14.Did the washer break completely? unknown 15.Was there audible and tactile feedback from the washer break? unknown 16.Was there adjusting knob issues? unknown 17.Did the anvil detach? unknown.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 the lap gastrectomy surgery, after fired, the knife moved to the distal end, but could not return knife automatically.Opened the device manually with big force.There were no adverse consequences to the patient.No additional information can be provided.

• Brand Name: N/A
• 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 ; 3035526892
• MDR Report Key: 25074172
• Report Number: 3005075853-2026-03374
• Device Sequence Number: 21505118
• Product Code: OCW
• UDI-Device Identifier: 10705036003502
• UDI-Public: (01)10705036003502(17)300430(10)A9802K
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K940967
• 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): 05/23/2026

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: ECS29A
• Device Lot Number: A9802K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 05/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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