MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CONTOUR CURVED CUTTER STAPLER; STAPLE, IMPLANTABLE

Catalog Number	CS40G
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 2/10/2025.D4 batch #436c35.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 cs40g device was received with no apparent damage and with a reload loaded in the device and a second reload (b) present.Both reloads (a and b) were received fully loaded with staples, with the washer uncut, with the drivers, and with the knife recess below the reload deck.The ledge of the lockout showed indentation.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 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.The reload was not properly loaded in the device, as the retaining pin was not connected to the coupler and pushrod.These facts indicate that the reload was removed and reinserted incorrectly and/or incompletely after the retainer was removed.The returned reload was pulled out of the device and placed back on; the device opened and closed without any difficulties.The device was tested for functionality with a returned 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 event reported was confirmed and it is related to improper use of the device.It should be noted that 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 the complete guide loading and reloading the instrument.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 436c35, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device gcs40g lot number a9d782 and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: 1.Could you please provide more for "gcs40g is cancelled"? 2.Please provide more details for each device malfunction.3.Did the device cut? 4.If the device cut/fired, was the cut line complete? 5.Did the device staple? 6.If the device stapled/fired, was the staple line complete? 7.If the device stapled, was the shape of the staples (b-formation, irregular, unformed)? 8.Did the device close? 9.Did the device fire? 10.Did the device open? 11.Was the device difficult to close on the tissue? 12.Was the device difficult to fire? 13.Was the device difficult to open? 14.On which firing did this occur? 15.Did the tissue retaining pin lock into the correct position? 16.Regarding "patient status/ outcome / consequences: yes,", please provide more details.
Event or Problem Description
It was reported that during an unknown procedure the device is not working the surgery was delayed 10 minutes.Changed the stapler.The procedure was successfully completed.There were no patient consequences.

• Brand Name: CONTOUR CURVED CUTTER STAPLER
• 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: 21344334
• Report Number: 3005075853-2025-01058
• Device Sequence Number: 15412996
• Product Code: GDW
• UDI-Device Identifier: 10705036012405
• UDI-Public: (01)10705036012405(17)280531(10)A9D782
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K040038
• 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): 02/10/2025

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: CS40G
• Device Lot Number: A9D782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CR40G.
• Patient Sex: Unknown