MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 33MM, CURVED; STAPLE, IMPLANTABLE

Model Number	ECS33A
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a esophageal procedure they could not attach the anvil.Opened the packing and found could not attach the anvil.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4), date sent: 7/18/2023, 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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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: 8/14/2023.D4: batch # u5at0c.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 ecs33a device arrived with no apparent damage.The breakaway washer was present and uncut, the device was fully loaded with staples, indicating that the device had not been fired.The device was tested for functionality with the returned washer and 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.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 u5at0c, and no non-conformances were identified.

• Brand Name: ILS 33MM, CURVED
• 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: 17344504
• Report Number: 3005075853-2023-05048
• Device Sequence Number: 12486167
• Product Code: GDW
• UDI-Device Identifier: 10705036012412
• UDI-Public: 10705036012412
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K940967
• 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
• Report Date (Section B): 08/14/2023

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: 01/31/2025
• Device Model Number: ECS33A
• Device Catalogue Number: ECS33A
• Device Lot Number: U93N17
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown