MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. ETHICON; Stapler, Surgical

Catalog Number	EC3D60S
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 10/07/2026.Additional information was requested, and the following was obtained: - the surgeon began using the ethicon 4000 stapler earlier this year and subsequently noted a concerning trend.When complications or other outlier events increase in frequency or severity, the surgeon evaluates whether they may be associated with the stapler, surgical technique, or other contributing factors to determine the appropriate course of action.Although an association with the stapler could not be confirmed, he transitioned back to the ethicon 3000 stapler because he had experienced fewer issues with that device.Regarding the bleeding complications, the surgeon could not determine whether the source was the staple line, the short gastric vessels during sleeve gastrectomy, or another vascular site.He also observed an increased incidence of malformed staples along the staple line.Despite maintaining compression for more than 15 seconds, the issue persisted, and the surgeon could not determine whether it was attributable to the stapler.- the surgeon confirmed using nuknit for the first three firings during sleeve gastrectomy procedures.For small-bowel procedures, the surgeon uses gia reloads to divide the bowel and mesentery because they are more cost-effective.Ethicon buttress material is used for all firings when creating the pouch.For sleeve gastrectomy procedures, blue reloads with buttress material are used.Nuknit is applied to the first three distal firings because it is less costly and the surgeon is less concerned about leaks in that portion of the staple line; buttress material is applied to the final three proximal firings.The surgeon generally uses green reloads, with black reloads reserved for thicker tissue, and uses green reloads for all sleeve gastrectomy firings.The surgeon does not oversew the staple lines and described the methods used to manage bleeding.- the surgeon indicated that the events were likely more attributable to patient-related factors, as most of the affected patients were older adults and smokers.He considered the events to be multifactorial and did not believe the stapler was the primary contributing factor.The surgeon stated that he intends to resume use of the ethicon 4000 stapler.He requested additional information regarding the device design and the studies conducted to confirm its performance before commercialization.

• Brand Name: ETHICON
• Common Device Name: Stapler, Surgical
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; PR 00969 ; +1(303)552-6892
• MDR Report Key: 50952435
• Report Number: 3005075853-2026-08155
• Device Sequence Number: 9499017
• Product Code: GAG
• UDI-Device Identifier: 10705036043522
• UDI-Public: 10705036043522
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K250385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: EC3D60S
• 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: 09/18/2026
• Initial Report FDA Received Date: 09/30/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown