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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a robot assisted unknown surgery, arterial bleeding occurred after stapling the gastric body.Hemostasis was performed with additional suture.After that, oozing and staple malformation were observed when performing a gastric-duodenal anastomosis using a device with a different lot.There was no effect on the patient.There was no blood transfusion performed.The cartridge color was blue.Additional suture was performed to complete the case.No additional information provided.
Additional Manufacturer Narrative
(b)(4) date sent: 9/18/2026 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.Additional information was requested, and the following was obtained: was there any other issue noted with the staple line other than bleeding (malformed staples, staple line missing staples, etc.)? how was the bleeding controlled? how much blood was lost (ml)? did the patient require a transfusion? was there any patient consequence or change in the post-operative care of the patient as a result of the event? no blood transfusion.Oozing occurred for 2¿3 days after surgery.There was no suture failure.Was there any other issue noted with the staple line other than bleeding (malformed staples, staple line missing staples, etc.)? yes.During the remnant stomach-duodenum anastomosis performed using a product from a different lot, oozing and incomplete staple formation were observed.No additional information regarding malformed staples or missing staples is available.How was the bleeding controlled? the arterial bleeding observed after stapling of the gastric body was controlled with additional suturing.The oozing and incomplete staple formation observed during the remnant stomach-duodenum anastomosis were also managed with additional suturing.How much blood was lost (ml)? unknown.Did the patient require a transfusion? no.No blood transfusion was required.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? no patient consequence was reported.Postoperatively, oozing persisted for approximately 2¿3 days; however, there was no anastomotic leakage reported.Can you please clarify if the oozing was observed on each of the five reloads or each firing? unknown.It was reported that arterial bleeding occurred after stapling of the gastric body and that oozing was observed during the remnant stomach-duodenum anastomosis using a product from a different lot.It is unknown whether oozing was observed with each of the five reloads or after each firing.Can you please provide details on staple line malformation? incomplete staple formation was observed during the remnant stomach-duodenum anastomosis.No further details regarding the appearance, extent, or specific characteristics of the staple line malformation are available.Can you please provide pictures/video? unknown.No information regarding the availability of pictures or video has been provided.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: how was the "oozing" that occurred for 2-3 days after surgery stopped? 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.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.

• Brand Name: ETHICON
• Common Device Name: Stapler, Surgical
• Manufacturer (Section D): 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: 50823663
• Report Number: 3005075853-2026-07701
• Device Sequence Number: 10152310
• Product Code: GAG
• UDI-Device Identifier: 10705036043522
• UDI-Public: (01)10705036043522(17)281231(10)A99E9H
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K250385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: EC3D60S
• Device Lot Number: A99E9H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/22/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/18/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2026
• 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: ER60B x5; ER60W
• Patient Sex: Unknown