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

Catalog Number	CS40G
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent 11/10/2025 d4 batch # unk attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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: did the device fire? was the device difficult to fire? did the device cut? if the device cut/fired, was the cut line complete? did the device staple? if the device stapled/fired, was the staple line complete? if the device was stapled, was the shape of the staples (b-formation, irregular, unformed)? is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during an unknown procedure the staples that do not penetrate the wall.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/11/2025.D4: batch # 873c64.Investigation summary: the product was returned to ethicon endo-surgery for thorough evaluation, which included visual inspections and functional testing of the returned device.Visual analysis of the returned sample revealed that the cs40g device was received with no apparent damage and with a reload present.The reload was received void of staples, with the washer completely cut, drivers exposed and the knife recess below the cartridge deck.In addition, some b-formed staples noted on the reload deck.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.The event described could not be confirmed as the device performed without any difficulties noted.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Device history review a manufacturing record evaluation was performed for the finished device batch number 873c64, and no non-conformances were identified.

• Brand Name: CONTOUR CURVED CUTTER STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 23511259
• Report Number: 3005075853-2025-08674
• Device Sequence Number: 9613425
• Product Code: GDW
• UDI-Device Identifier: 10705036012405
• UDI-Public: (01)10705036012405(17)290228(10)C9DM97(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: C9DM97
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown