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

Catalog Number	CR40G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The device was received with no complaint information.Attempts were made to reconcile the device with no success resulting in the creation of a new complaint.
Additional Manufacturer Narrative
(b)(4) date sent: 5/14/2026 b3: exact event date unk, entered 1/1/2026 as only the year was provided.D4: batch # 667d68 e1: unk reporter.Investigation summary the product was returned to ethicon endo surgery for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample determined that the cr40g reload was received with all staples protruding, the washer uncut, and the knife recessed below the reload deck.The drivers were noted to be partially advanced.No functional test was performed due to the condition of the reload.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.Please reference instructions for use for additional information.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 667d68, and no non-conformances were identified.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.

• Brand Name: CONTOUR
• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 25177618
• Report Number: 3005075853-2026-03668
• Device Sequence Number: 18738187
• Product Code: GDW
• UDI-Device Identifier: 10705036001430
• UDI-Public: (01)10705036001430(17)280731(10)667D68
• Combination Product (Y/N): N
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: CR40G
• Device Lot Number: 667D68
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• 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