MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 33MM CURVED; STAPLE, IMPLANTABLE

Catalog Number	CDH33A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
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 6/11/2025.D4 batch #u5ax9l.B3: only event year known: 2025.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 cdh33a device arrived with no apparent damage along with the anvil inside a plastic bag and the shaft of the anvil returned damaged (bent).The anvil lock spring was in good condition and the trocar had some scratches.It is possible that the scratches on the trocar were caused trying to insert the anvil.Only one staple was present protruding in the pocket and the breakaway washer was uncut and it had a mark.Upon visual inspection a slight damage was found on the guide face in the same area than washer.Also, the safety had scratches.It appears that an attempt was made to fire the device with the safety engaged.It should be notice that to fire the device, draw the red safety back toward the adjusting knob until it seats into the body of the device.If the safety cannot be released, the device is not in the safe firing range.The device was reloaded with staples and tested for functionality with a test anvil and a test washer; the device formed all the staples, as well as completely cut the test media and the breakaway washer without incident.The staple line was complete and the staples meet the staple form release criteria.No conclusion could be reached on what caused the damage of the anvil.The condition of the washer indicates that the device had not been fired through a full firing stroke, the orange indicator was not fully into the safe green firing range or the anvil was not reattached correctly.It should be noted that before firing, ensure that the orange indicator is fully within the green range of the gap setting scale and the anvil is reattached correctly.To reattach the detachable head or anvil do not clamp across or grip on the locking springs as it might not click into place.Not reattaching the anvil correctly or the orange indicator not being set on the green range will result in a bigger gap between the anvil and the guide face, therefore the staples will not hit the anvil to make b- formed staples.In addition, if the firing sequence is not complete, staples could be partially deployed without cutting the washer.Please reference the 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.A manufacturing record evaluation was performed for the finished device batch number u5ax9l, and no non-conformances were identified.

• Brand Name: ILS 33MM CURVED
• 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: 22183054
• Report Number: 3005075853-2025-04410
• Device Sequence Number: 12908630
• Product Code: GDW
• UDI-Device Identifier: 10705036003472
• UDI-Public: (01)10705036003472(17)250228(10)U5AX9L
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K983536
• 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): 06/11/2025

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 Expiration Date: 02/28/2025
• Device Catalogue Number: CDH33A
• Device Lot Number: U5AX9L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2020
• 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