MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CIRCULAR MECH XL SEAL 21MM; STAPLE, IMPLANTABLE

Model Number	ECS21B
Medical Device Problem Codes	No Apparent Adverse Event (3189); Ejection Problem (4009)
Health Effect - Clinical Codes	Failure to Anastomose (1028); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 7/5/2023.D4: batch # unk.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.No lot or batch number was provided therefore a device history could not be done.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 the robotic gastric bypass procedure the device was defective at the anvil causing a hole in the anastomosis.The hole was repaired with suture.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent: 8/3/2023 d4; batch # u5ar6j investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the ecs21b device arrived with no apparent damage.The breakaway washer was present, cut and there were no staples present, indicating that the device achieved a full firing stroke.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.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: insert the device up to the closed lumen with the anvil removed and the trocar fully retracted.Fully extend the trocar and pierce tissue by gently rotating the instrument while holding the adjusting knob.Push the tissue down until the orange tying area is visible.Reattach the anvil by sliding the anvil shaft over the trocar and pushing until the anvil snaps into its fully seated position.If excessive force is required to close the device, this may indicate there is too much tissue or thickened tissue in the device.Attempting to fire the instrument in this condition may result in poor staple line integrity with possible leakage or disruption.In addition, instrument damage or failure may result.The event described could not be confirmed as the device performed without any difficulties.A manufacturing record evaluation was performed for the finished device batch number u5ar6j, and no non-conformances were identified.Additional information was requested, and the following was obtained: 1.Could you please provide more details for "device was defective"? 2.Could you please clarify if there were any patient consequences? 3.Could you please clarify if was any change in the post-operative care of the patient as a result of the event? answer : 1.¿the staple did not fire properly and caused a hole in her anastomosis.¿ 2.¿this was oversewn with 3-0 vicryl and then oversewn once again with imbrication.¿ so at a minimum there was extended anesthesia time and risk for leakage from an overseen unintended hole.3.It appears this did not alter the patient¿s post-operative course.

• Brand Name: CIRCULAR MECH XL SEAL 21MM
• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17263714
• Report Number: 3005075853-2023-04599
• Device Sequence Number: 20811234
• Product Code: GDW
• UDI-Device Identifier: 10705036022916
• UDI-Public: 10705036022916
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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 Expiration Date: 02/28/2025
• Device Model Number: ECS21B
• Device Catalogue Number: ECS21B
• Device Lot Number: U5AR6J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown