MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON CONTOUR W/ BLUE RELOAD; STAPLE, IMPLANTABLE

Catalog Number	GCS40B
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 11/7/2024.D4 batch # 196d53.B3: only event year known: 2024.Investigation summary : the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the gcs40b device was received with no apparent damage with a cr40b reload loaded and a second cgr40b reload (b) present.The reload loaded was received void of staples and reload (b) was received fully loaded with staples, the drivers and knife recessed below the cartridge deck, also, it was noted that reload was not properly loaded.Since, one of tracks of reload were damaged and the retaining pin was up.This fact indicate that the reload was removed and tried to insert incorrectly and/or incompletely after the retainer was removed.The device was tested for functionality with a test reload and it fired, cut, and formed the staples as intended.The cut line and the staple line were completed and the staples meet the staple form release criteria.As part of our quality process, the manufacturing records of this batch were reviewed, and the manufacturing standards were met prior to the release of this batch.The event reported was confirmed and it is related to improper use of the device.It should be noted that to reload the device insert the new reload into the metal housing and snap it into position.The tracks on each side of the reload should be used as guides to align the reload within the jaws of the instrument.When the reload is properly aligned, push the reload into the instrument until it is fully seated.Remove the staple retainer.Check that the reload is held firmly within the jaws.If the reload is removed from the device, whether the reload is spent or not, and if the staple retainer has already been removed from the reload, the reload cannot be reloaded into the device.Please reference the instructions for use for additional information.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 196d53, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure the cartridge did not fire.

• Brand Name: ECHELON CONTOUR W/ BLUE RELOAD
• 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: 20629980
• Report Number: 3005075853-2024-08439
• Device Sequence Number: 20815392
• Product Code: GDW
• UDI-Device Identifier: 10705036027515
• UDI-Public: (01)10705036027515(17)290630(10)196D53(21)
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200420
• 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): 11/07/2024

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: GCS40B
• Device Lot Number: 196D53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown