MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX 45 LONG; STAPLE, IMPLANTABLE

Model Number	EC45AL
Medical Device Problem Codes	Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch #442a17.(b)(4).Additional information was requested and the following was provided: what was the surgical procedure? robotic nephrectomy.What were the indications for the procedure? n/a.What was the exact tissue that they attempted to staple over? vessels.Did the surgeon consider other alternatives other than stapling because of the calcification? multiple staplers.What is meant by unable to close the device? could not close the handle.Please clarify if bleeding occurred, before, during, or after the use of the device: after.Did the device get fired? yes.How was the procedure completed? had to open.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 revealed that one ec45al device was returned with no apparent damage and with a gst45w reload loaded in the device.The reload was received unfired.In an attempt to replicate the reported incident the clamping mechanism was non functional.No functional test could be performed due to the condition of the device.The device was disassembled to verify the condition of the internal components and the yoke was noted to be broken.In addition, a tyvek was received along with the device.The event reported was confirmed and it is related to improper use of the device.The damaged observed is associated with an attempt to close the device on heavily calcified tissue.Please reference the instruction for use for more information.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot and batch 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 filed as appropriate.
Event or Problem Description
It was reported that during an unknown procedure the surgeon tried to use multiple staples across very calcified tissue.He was unable to close the device.After several attempts this stapler was able to close on vessel.The patient began to bleed and several units of blood were used.

• Brand Name: ECHELON FLEX 45 LONG
• 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 00969 ; * 00969
• MDR Report Key: 13901943
• Report Number: 3005075853-2022-01807
• Device Sequence Number: 11879790
• Product Code: GDW
• UDI-Device Identifier: 10705036001683
• UDI-Public: 10705036001683
• Combination Product (Y/N): N
• PMA/510(K) Number: K051002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: EC45AL
• Device Catalogue Number: EC45AL
• Device Lot Number: V95R6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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: GST WHITE RELOAD, 45MM, 6 ROW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown