MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETHICON 4000 STAPLER STRAIGHT 60 LONG; 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	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the surgeon to the sales rep that some photos he thought the distal part of the staple line dd not look normal, almost as if it opened up a little.The surgeon said the procedure went great.There was no patient consequence nor surgical delay reported.No additional information provided.
Additional Manufacturer Narrative
(b)(4) date sent: 3/3/2026 b3: only event year known: 2026 d4: batch #unk d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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: what was the appearance of the deployed staples (b-formed, malformed, goal post/legs straight)? were there staples missing from the staple line? what was the surgical procedure? what was the anatomical structure that was being fired on when the issues occurred? was it observed on one firing or rapid firing? how many times was the device fired? what is meant by " distal part of the staple line didn't look normal"? is the video available for review? what was the doctor's name? no lot or batch number was provided; therefore, a device history could not be done.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/7/2026.Investigation summary: this is an analysis of photos submitted for evaluation.During the visual analysis, the following was observed: one piece of tissue with a staple line was observed however, due to tissue on staples line improper form of staples cannot be determined.Based on the photos the event described could not be confirmed.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.

• Brand Name: ETHICON 4000 STAPLER STRAIGHT 60 LONG
• 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: 24496324
• Report Number: 3005075853-2026-01712
• Device Sequence Number: 5104891
• Product Code: GAG
• UDI-Device Identifier: 10705036043546
• UDI-Public: 10705036043546
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 03/03/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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