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

Catalog Number	EC3D60S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, following a gastric bypass procedure, the patient experienced postoperative mesenteric bleeding and was transferred to the intensive care unit.The patient has remained in rehabilitation since 9/15.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4) date sent: 9/30/2026 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 were the indications for surgery? was buttress material used? was nuknit used as a hemostasis agent? if so, how was it being used? did the patient receive any preoperative chemotherapy or radiation? what is the lot/batch number? were there any issues experienced with the device in the initial surgical procedure? what healthcare professional fired the device and what is his/her experience with the device? did the healthcare professional wait 15 seconds after closing the device before firing? were there any issues with opening the device? if yes, what trouble shooting steps were used to open the device? were there any issues noted with staple formation at any point throughout the care of the patient? if so, please describe the shape and location.What color reloads were used and what was the sequence of the firings? was a leak test performed? if so, what type and what was the result? was the staple line visualized endoscopically during the initial surgical procedure? how was the post-op bleeding identified? how many days postoperative was the bleeding identified? what was the total estimated blood loss (ml)? was a transfusion required? how was the bleeding addressed? what treatment patient received postop? was rehab part of the treatment for the complications? what was the pre and postoperative anti-coagulant and pain management protocol? what is the current patient status? please provide timeline of events.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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: 10/05/2026.Additional information was requested, and the following was obtained: what were the indications for surgery? bariatric sleeve and hiatal hernia repair was buttress material used? yes slr was nuknit used as a hemostasis agent? if so, how was it being used? on stapler as a buttress did the patient receive any preoperative chemotherapy or radiation? no what is the lot/batch number? unknown were there any issues experienced with the device in the initial surgical procedure? no what healthcare professional fired the device and what is his/her experience with the device? yes did the healthcare professional wait 15 seconds after closing the device before firing? yes were there any issues with opening the device? if yes, what trouble shooting steps were used to open the device? no were there any issues noted with staple formation at any point throughout the care of the patient? if so, please describe the shape and location.No what color reloads were used and what was the sequence of the firings? 5 green, first 3 with nuknit then 2 with slr was a leak test performed? if so, what type and what was the result? yes no leak was the staple line visualized endoscopically during the initial surgical procedure? yes how was the post-op bleeding identified? pain, then ct scan how many days postoperative was the bleeding identified? 2-3 days unsure what was the total estimated blood loss (ml)? 5 ml was a transfusion required? yes 24 bags of blood given how was the bleeding addressed? open case and then to icu, then to rehab what was the pre and postoperative anti-coagulant and pain management protocol? unknown what is the current patient status? doing better out of hospital please provide timeline of events.Procedure date on (b)(6) (unsure of initial date) taken back to operating room on (b)(6) 2026 for an open procedure to get the blood loss under control, then transferred out to another hospital with icu and then rehab.

• 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: 50947440
• Report Number: 3005075853-2026-08123
• Device Sequence Number: 15840883
• 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?: Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3D reloads; HAR1136; NUKNit; SLR
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown