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

Model Number	GCR40G
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pc (b)(4).Date sent: 04/21/2023.Only event year known: 2023.Batch # 957a26 additional information was requested, and the following was received: could you please provide more details for "reload seemed to be defective"? this is the exact quote from customer¿.¿just to clarify it was the staple load that seemed to be defective.Stapler worked fine.¿ no other info was given.The closing handle wouldn¿t close.Could you please clarify if there was any physical damage found? no physical damage was found.The reload in question was the original load that comes preloaded in the device and not an additional reload.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 revealed that the gcs40g device was received with no apparent damage and with a gcr40g reload loaded.The reload was received fully loaded with staples, with the washer uncut and with the driver's and knife recessed below the cartridge deck.The ledge of the lockout showed indentation.The device was tested for functionality with the returned sample reload and the device fired, forming all staples and cutting as intended.The cut line and the staple line were completed and the staples meet the staple form release criteria.The device lockout and the cartridge lockout were functional, and the device fired without any difficulties.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The event reported was confirmed and it is related to improper use of the device.It is possible that an attempt was made to close the device with a reload not properly loaded or with a spend reload, this condition would lock the device giving the impression that the device will not close.The echelon contour¿ curved cutter is designed with a feature that prevents closure if a used reload, no reload, or an incorrectly inserted reload is in the instrument.The used or misloaded reload module should then be replaced with a new reload or, if no reload was present, a reload should be loaded in the instrument.After following the above steps, any device which does not close either partially or completely should not be used.Please reference the instruction for use for more information.A manufacturing record evaluation was performed for the finished device batch number 957a26, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure the reload seemed to be defective.When i picked up the stapler, the closing handle wouldn't close.I pushed the reload in further and closing handle closed and seemed to be ok.There were no patient consequences.

• Brand Name: ECHELON CONTOUR GST RELOAD GREEN
• 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: 16790975
• Report Number: 3005075853-2023-02787
• Device Sequence Number: 17568943
• Product Code: GDW
• UDI-Device Identifier: 10705036027478
• UDI-Public: 10705036027478
• 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): 04/21/2023

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 Expiration Date: 07/31/2025
• Device Model Number: GCR40G
• Device Catalogue Number: GCR40G
• Device Lot Number: 932A51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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: GCS40G
• Patient Sex: Unknown