MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CIRCULAR MECH XL SEAL 25MM; STAPLE, IMPLANTABLE

Model Number	ECS25B
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of event: unknown, captured as awareness date.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 lot/batch was not provided; therefore, the manufacturing record 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 field as appropriate.
Event or Problem Description
It was reported that during an unknown procedure, the anvil could not be removed from the trocar.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 09/12/2022.D4: batch # 375a58.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that the ecs25b device arrived with no apparent damage, with the breakaway washer uncut and without marks, and there were staples present.Further analysis of the device showed that the trocar was damaged.However, the anvil returned allowed that the anvil assembles on the device.Once the anvil was attached to the device it was slightly difficult to remove.No functional test was performed due to condition of the device.No conclusion could be reached as to how the trocar became damaged.In addition, a tyvek was received along with the device.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 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: CIRCULAR MECH XL SEAL 25MM
• 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 ; 329348013
• MDR Report Key: 15146001
• Report Number: 3005075853-2022-05025
• Device Sequence Number: 5748586
• Product Code: GDW
• UDI-Device Identifier: 10705036022923
• UDI-Public: 10705036022923
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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: 06/30/2026
• Device Model Number: ECS25B
• Device Catalogue Number: ECS25B
• Device Lot Number: 375A58
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown