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

Catalog Number	EC3D60C
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	05/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent 6/8/2026.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.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.No lot or batch number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: was there any other issue noted with the staple line other than bleeding/oozing (malformed staples, staple line missing staples, etc.)? no.2.How was the bleeding controlled? patient was kept in the hospital until the bleeding was controlled.3.How much blood was lost (ml)? i am unaware and the physician is out of the country for two weeks.4.Did the patient require a transfusion? i am unaware.5.How was the bleeding addressed? patient was kept in the hospital until the bleeding was controlled.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 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 was the pre and postoperative anti-coagulant and pain management protocol? was the bleeding intraluminal or extraluminal? were the staples the appropriate b-shape form? any clips, clamps, or graspers near the area where the device was being fired? what was done to address the bleeding when it was first noticed intraoperatively? what measures were taken to ensure that it was safe to close out the patient? were there postoperative complications or symptoms that became known? what postoperative care was provided for the patient? was this the first or subsequent firings for the device? please confirm that the hospitalization was extended due to the difficulties of 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? please provide a timeline of events.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 colectomy procedure, the staple line was bleeding.No additional information was provided.
Additional Manufacturer Narrative
(b)(4) date sent: 6/23/2026 additional information was requested, and the following was obtained: how was the post-op bleeding identified? blood filling toilet - how many days postoperative was the bleeding identified? next day - what was the total estimated blood loss (ml)? 300ml - was a transfusion required? no - how was the bleeding addressed? holding debt profalaxisys and waiting - what was the pre and postoperative anti-coagulant and pain management protocol? eras pain management start sub q hebron next morning - was the bleeding intraluminal or extraluminal? intra - were the staples the appropriate b-shape form? couldn't see - any clips, clamps, or graspers near the area where the device was being fired? no - what was done to address the bleeding when it was first noticed intraoperatively? not noticeable intra - what measures were taken to ensure that it was safe to close out the patient? n/a - were there postoperative complications or symptoms that became known? bleeding - what postoperative care was provided for the patient? - was this the first or subsequent firings for the device? subsequent - please confirm that the hospitalization was extended due to the difficulties of 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? blue - was a leak test performed? if so, what type and what was the result? no - please provide a timeline of events.Procedure, next day symptom occurred, kept in hospital 5 days.

• 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 ; 3035526892
• MDR Report Key: 25432446
• Report Number: 3005075853-2026-04366
• Device Sequence Number: 13309362
• Product Code: GAG
• UDI-Device Identifier: 10705036043539
• UDI-Public: 10705036043539
• Combination Product (Y/N): N
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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: EC3D60C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/27/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 06/23/2026
• 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; Required Intervention
• Patient Sex: Unknown