MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GOLD RELOAD FOR ECHELON 45; STAPLE, IMPLANTABLE

Catalog Number	ECR45D
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 9/12/2024 d4: batch # 260c63 investigation summary the product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample determined that one ecr45d reload was received partially fired 1/2 with the reload pan partially dislodged from the left proximal side.In addition, 1 double driver is out of position, making the reload non-functional.No functional test was performed due to the condition of the reload.The partially fired is consistent with an incomplete or interrupted cycle.It is possible that handling by the customer could dislodge the pan.Dislodgement as a result of the removal of the reload from the device is the most likely scenario.Please reference the instruction for use for more information.Device history review a manufacturing record evaluation was performed for the finished device batch number 260c63, and no non-conformances were identified.
Event or Problem Description
It was reported that during the laparoscopic lobectomy surgery, could not fire.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.

• Brand Name: GOLD RELOAD FOR ECHELON 45
• 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
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 20201608
• Report Number: 3005075853-2024-06836
• Device Sequence Number: 6674935
• Product Code: GDW
• UDI-Device Identifier: 10705036001737
• UDI-Public: (01)10705036001737(17)280130(10)338C52
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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: ECR45D
• Device Lot Number: 338C52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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