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

Catalog Number	GCS40B
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rectum procedure the instrument could no longer be closed or fired after initial closing and repositioning on the tissue.No patient harm nor significant delay reported.Procedure finished successfully with same like device.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/22/2024 d4: batch #781c88 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 and with a reload loaded in the device.The reload was received with the drivers partially advanced, washer uncut, with the knife recessed below the reload deck and all staples inside the pockets.The device was tested for functionality with a test 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.In addition, the ledge of the lockout showed slight indentation.The condition of the reload is consistent with the device being partially activated.As a result of the partial firing the lockout was engaged when the device was reopened.Do not fire the instrument unless the closure trigger is properly latched against the handle.The firing trigger must be pulled back completely against the closure trigger to properly fire the instrument.In addition, if the firing sequence is not complete, you could deploy the staples without cutting the washer and forming the staples.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.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 781c88, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device gcs40b lot number c9d90a and no non-conformances were identified.

• 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: 19590925
• Report Number: 3005075853-2024-04606
• Device Sequence Number: 3314976
• Product Code: GDW
• UDI-Device Identifier: 10705036027515
• UDI-Public: 10705036027515
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2024

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: C9D90A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 06/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown