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

Catalog Number	EC3D60L
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/28/2026.D4: batch#: unk.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 what is meant by ¿staples malformed¿.Please describe the shape.Was it in b formation? was buttressing used? how were the malformed staples addressed? was there an intervention done on the distal 1/3 of the malformed staples? was the malformed staple line viewed on the remnant or the remaining pancreas? 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#: ec3d60l, with lot/batch#: a9944h, and no non-conformance's 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.
Event or Problem Description
It was reported that during a distal pancreatomy procedure, the surgeon fired the stapler across the pancreatic tissue.During an inspection of the staple line, the surgeon was impressed by the quality of the stapler on the remaining organ.After the inspection of the staple line on the specimen being removed, the surgeon noticed that the distal 1/3 of the staples were malformed.There was no patient consequence nor surgical delay reported.No additional information provided.

• Brand Name: ETHICON
• 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: 25017832
• Report Number: 3005075853-2026-03178
• Device Sequence Number: 10294878
• Product Code: GAG
• UDI-Device Identifier: 10705036043546
• UDI-Public: (01)10705036043546(17)281031(10)A9944H
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K241630
• 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): 04/28/2026

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
• 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: 05/12/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/31/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ER60T.
• Patient Sex: Unknown