MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. N/A; STAPLE, IMPLANTABLE

Catalog Number	CDH25A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 3/27/2026.D4: batch # unk.The device/photo upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: is the current patient status known? -discharged.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) -no.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 the esophgeal - gastric anastomosis surgery, the fire was not completed and the device could not be removed.An electrotome was used to cutoff the tissue and remove the device.Finally, suture was used to sew the wound.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/10/2026.D4: batch # 772d68.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 cdh25a device arrived with no apparent damage.Only anvil half washer was present and there were no staples present, indicating that the device achieved a full firing stroke.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality.It fired and 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.The event described could not be confirmed as the device fired without any difficulties noted and it was returned without detectable damage.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 772d68, and no non-conformances were identified.

• Brand Name: N/A
• 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: 24717145
• Report Number: 3005075853-2026-02329
• Device Sequence Number: 17664356
• Product Code: GDW
• UDI-Device Identifier: 10705036003458
• UDI-Public: (01)10705036003458(17)300930(10)796D63
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 04/10/2026

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: CDH25A
• Device Lot Number: 796D63
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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