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	02/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 a hemicolectomy, the ancillary trocar could be fitted onto the trocar of ecs.But removal was very difficult.Removed it by lot of struggle.Later they used linear cutter to complete the procedure.No fragments were generated.The procedure was completed successfully.The surgery was completed as usual.The current status of the patient is unknown.
Additional Manufacturer Narrative
(b)(4) date sent: 04/30/2021.D4: batch # u5c30d.H6: component code = others (g07).Device analysis: 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 and an ancillary trocar was received.During the functional testing, the ancillary trocar was assembled and removed from the anvil shaft without difficulty.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: the ancillary trocar is designed to facilitate controlled penetration through tissue selected by the surgeon.For example, a surgeon may elect to use the ancillary trocar to perform a triple stapling technique or end-toside anastomosis.Keep the trocar visible at all times to prevent personal injury or inadvertent trauma to adjacent structures.The event described could not be confirmed as the ancillary trocar, anvil and the device performed without any difficulties.A manufacturing record evaluation was performed for the finished device batch number, 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
• MDR Report Key: 11394048
• Report Number: 3005075853-2021-01164
• Device Sequence Number: 3286878
• Product Code: GDW
• UDI-Device Identifier: 10705036012412
• UDI-Public: 10705036012412
• Combination Product (Y/N): N
• 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,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

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: 02/25/2025
• Device Model Number: ECS33A
• Device Catalogue Number: ECS33A
• Device Lot Number: U93V7F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 04/30/2021
• Patient Sequence Number: 1