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

Catalog Number	ECR45G
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown surgery, could not fire.Changed the new one to complete surgery.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent 10/8/2024.D4 batch #256c46.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample determined that one ecr45g reload was received for analysis.The reload was received with no apparent damage and the sled was received in the home position; however, it were noted the two first staples missing, this condition was most likely due to the premature sled movement.The condition of the driver's up shows that reload was partially fired 1/10 causing the reported event.However, it is possible that the reload was manipulated, and the sled was manually returned to its home position.Additionally the pan was received partially dislodged from the distal side with one loose driver in the channel.No functional test was performed due to the condition of the reload.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.It is also 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.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 256c46, and no non-conformances were identified.Additional information was requested, and the following was obtained: is the current patient status known?? discharged.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? no.

• Brand Name: GREEN 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: 20395982
• Report Number: 3005075853-2024-07535
• Device Sequence Number: 20474491
• Product Code: GDW
• UDI-Device Identifier: 10705036001744
• UDI-Public: (01)10705036001744(17)261230(10)256C46
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2024

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: ECR45G
• Device Lot Number: 256C46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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 Age: 71 YR
• Patient Sex: Female