MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CIRCULAR MECH XL SEAL 29MM; STAPLE, IMPLANTABLE

Catalog Number	ECS29B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during intestinal rechanalisation surgery, a termino-lateral mechanical trans-anal colorectal anastomosis is packaged.Free of tension with circular mechanical stapler.Both suture rings appear undamaged.Then there is a large dehiscence of the anterior wall with the leakage of fecal material.Need to remove anastomosis and pack a new latero-terminal anastomosis with another stapler.In view of pelvic contamination and tissue fragility, it is considered appropriate to protect anastomosis by ileostomy.
Additional Manufacturer Narrative
(b)(4).Date sent 5/28/2025.D4 batch # unk.H6: health effect ¿ clinical code gastrointestinal system (e10).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 manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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? what surgical procedure was performed? did the patient receive any preoperative chemotherapy or radiation? 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? where in the green gap setting scale was the indicator located prior to firing (low-b, middle-b, or high-b)? did the healthcare professional wait 15 seconds after closing the device and then retighten prior to firing? was the device difficult to close? was the device difficult to fire? how may counter-clockwise revolutions of the adjusting knob were used to open the device? did the healthcare professional receive audible & tactile feedback when firing the device? were the donuts inspected? if so, please describe.Was a complete transection of the white breakaway washer visually confirmed? 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 is the current status of the patient? does the surgeon believe the post-operative complications were related to an alleged deficiency of the device or were there other contributing factors to include patient tissue condition? 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 many days postoperative did the leak occur? how was the leak identified? what was observed at the site of the leak upon reoperation? how was the leak addressed? 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: 6/10/2025.Additional information was requested, and the following was obtained: what were the indications for surgery? cr anastomosis.What surgical procedure was performed? left colon surgery.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? professional surgeon.Where in the green gap setting scale was the indicator located prior to firing (low-b, middle-b, or high-b)? high-b.Did the healthcare professional wait 15 seconds after closing the device and then retighten prior to firing? yes was the device difficult to close? no was the device difficult to fire? no how may counter-clockwise revolutions of the adjusting knob were used to open the device? 2 did the healthcare professional receive audible & tactile feedback when firing the device? yes was a complete transection of the white breakaway washer visually confirmed? don't know what is the current status of the patient? the patient was discharged does the surgeon believe the post-operative complications were related to an alleged deficiency of the device or were there other contributing factors to include patient tissue condition? both.Was the staple line visualized endoscopically during the initial surgical procedure? no.
Additional Manufacturer Narrative
(b)(4).Date sent 7/9/2025.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent 7/15/2025.D4 batch #442d29.Corrected data d4: udi #.Investigation summary: the product was returned for thorough evaluation, which included visual inspections and functional testing of the returned device.Visual analysis of the returned sample revealed that the ecs29b device arrived with no apparent damage.Only the anvil half washer was present, and there were no staples present, indicating that the device achieved a full firing stroke.In addition, the washer and knife were noted to have nicks.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality.It fired and formed all the staples as well as completely cut the test media and the breakaway washer without incident.The staple line was complete, and the staples meet the staple form release criteria.The event reported was confirmed and it is related to improper use of the device.The damage on the knife and washer is consistent when the device is fired over an already existing staple line, hard object or thicker tissue than indicated.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 442d29, and no non-conformances were identified.

• Brand Name: CIRCULAR MECH XL SEAL 29MM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 22104640
• Report Number: 3005075853-2025-03994
• Device Sequence Number: 8233480
• Product Code: GDW
• UDI-Device Identifier: 10705036022930
• UDI-Public: (01)10705036022930(17)300131(10)A97P2H
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/15/2025

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: ECS29B
• Device Lot Number: A97P2H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 06/05/2025; 07/08/2025; 07/11/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/10/2025; 07/09/2025; 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Unknown