MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. N/A; STAPLE, IMPLANTABLE

Catalog Number	CDH29A
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown surgery, open the packing and noted that some staples fell off.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent 8/10/2026.D4 batch #.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 revealed that the cdh29a device arrived with no apparent damage with the anvil and stapler retainer inside a plastic bag.Upon visual inspection the staples were observed slighlty protruding inside the pockets and one staple was missing.Further analysis shows that the staples retainer has marks of the staples.It appears that an attempt was made to fire the device with the retainer placed.During the mechanical assessment, the handle was actuated to inspect the knife and staples.It was observed that after opening the handle, the knife remained slightly exposed, and the staples were also observed to remain exposed and could not be restored to their original position.The device was disassembled in order to verify the condition of the internal components and the driver links were found to be disengaged from the compression element due to the damage noted on the legs of the drivers and the compression element.No functional test was performed due to the condition of the device.No conclusion could be reached on what caused the damage on legs of the drivers and compression element.Regarding the missing staple and protruding staples, it should be noted that an inadvertent movement of the firing trigger after disengaging the safety might cause the staples to fall out.It is important to ensure that the adjusting knob is set in the firing range before disengaging the safety.Therefore, it is imperative that disengaging the safety be the last step prior to firing.Please reference the instruction for use for more information.Batch records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.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 555d73, and no non-conformances were identified.Manufacturing date 05/09/2025 expiration date 04/30/2030 for cdh29a, 577d37 this entry records a complaint-related verification of sap date fields only.

• Brand Name: N/A
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50193953
• Report Number: 3005075853-2026-06442
• Device Sequence Number: 9998218
• Product Code: GDW
• UDI-Device Identifier: 10705036003465
• UDI-Public: (01)10705036003465(17)300430(10)577D37
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: CDH29A
• Device Lot Number: 577D37
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2025
• 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