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

Catalog Number	CDH25A
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a lap gastrectomy the spring at the base of stapler spring open, which cannot be docked with the stapler head.Changed the new one to complete surgery.No additional information can be provided.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/2/2026.D4: batch#: 604d58.This is an analysis of a photo submitted to ethicon endo surgery for evaluation.During the visual analysis, the following was observed: the photo shows an anvil with the locks protruding of anvil shaft, a washer uncut with body fluids on it and with an inserted ancillary trocar.Based on the photo the event described is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.As part of ethicon endo surgery 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 of 604d58 / 50cdh25a, and no non-conformance's were identified.Additional information was requested and the following was obtained: 1.Was there a patient consequence? no.2.Could you please clarify if there were any change in the post-operative care of the patient as a result of the event? 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/24/2026.D4: batch # 578d00.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 determined that the cdh25a device arrived with no apparent damage, with the anvil not inserted.The breakaway washer was present, uncut and there were staples present.Further analysis shows that the anvil was received with the locking spring of anvil damage.In addition, scratches were noted on this area.No functional test was performed due to the condition of the anvil.The event reported was confirmed and it is related to improper use of the device.Do not clamp across or grip on the locking springs when attempting to reattach the anvil.To avoid inclusion of tissue within the anvil shaft, do not use it for piercing.Instead, insert the ancillary trocar (included with stapler) into the anvil shaft as described in the section on ¿use of ancillary trocar.¿ please reference the instruction for use for more 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 578d00, 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: 24769420
• Report Number: 3005075853-2026-02467
• Device Sequence Number: 21348147
• Product Code: GDW
• UDI-Device Identifier: 10705036003458
• UDI-Public: (01)10705036003458(17)300530(10)604D58
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 604D58
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2025
• 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