MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX 60 COMPACT; STAPLE, IMPLANTABLE

Catalog Number	SC60A
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, after fired, noted the staples malformed.Changed another one to continue the surgery, the same problem happened again.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/21/2023.D4: batch # unk.A manufacturing record evaluation was performed for the finished device lot/batch number, a9c37v, and no non-conformances were identified.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.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: 12/28/2023.Device evaluation anticipated, but not yet begun.
Additional Manufacturer Narrative
(b)(4) date sent: 1/24/2024 d4: batch # 255c83 investigation summary the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the one sc60a device was returned with the anvil bent upwards and with two cecr60b reloads(b and c) present.The reload(b) was received partially fired 1/16 with no apparent damage, the reload(c) was received partially fired 1/2 with damaged deck.Furthermore, the anvil knife slot was noted to be damaged.The damage on the reload(c) is consistent with damage to the knife slot.No functional test was performed due to the condition.Regarding the condition of the reload(b).It is possible that while loading the reload, the reload was pushed farther back than the reload alignment slot resulting in the knife pushing the one-piece sled forward and locking the reload.Please reference the instruction for use for more information.Regarding the condition of the reload(c) and damaged anvil, the partially fired is consistent with an incomplete or interrupted cycle.It is possible that the device was clamped over an excess of tissue causing the anvil to bend and for the firing stroke and the staple form to be incomplete.It should be noted that a 100% inspection takes place during manufacturing to ensure the device meets the required specifications prior to shipments, in addition, a sample of the batch is inspected finished good quality assurance.Please reference the instruction for use for more information.As part of ethicon ¿s quality process all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached on what may have caused the missing staples.It should be noted that all devices are inspected 100% for staple presence by an automated vision system and are visually inspected 100% as a final check.Device history review a manufacturing record evaluation was performed for the finished device batch number 255c83, and no non-conformances were identified.

• Brand Name: ECHELON FLEX 60 COMPACT
• 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: 18183589
• Report Number: 3005075853-2023-08645
• Device Sequence Number: 7653077
• Product Code: GDW
• UDI-Device Identifier: 10705036002710
• UDI-Public: 10705036002710
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081146
• 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
• Report Date (Section B): 01/24/2024

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: 12/31/2025
• Device Catalogue Number: SC60A
• Device Lot Number: A9C37V
• 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: 10/27/2023
• Supplement Date Received by Manufacturer: 12/05/2023; 01/12/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/28/2023; 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CECR60B
• Patient Sex: Unknown