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

Catalog Number	SC60A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, the jaws didn't close all the way.At the time of the call it was unknown how the case was completed.No patient harm was reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/12/2024.B3: only event month and day known.Year is unknown but assumed to be the year that the complaint was reported.Investigation summary : the product was returned to ethicon endo surgery 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 no reload present.No functional test was performed due to the condition.The reported event was confirmed and related to improper use of the device.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 shipment, in addition, a sample of the batch is inspected for finished good quality assurance.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 435c46, 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo ; *
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 19518499
• Report Number: 3005075853-2024-04310
• Device Sequence Number: 8251192
• Product Code: GDW
• UDI-Device Identifier: 10705036002710
• UDI-Public: 10705036002710
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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 Catalogue Number: SC60A
• Device Lot Number: 435C46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown