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

Catalog Number	CDH25B
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the circular stapler misfired during the procedure.Was there any reported patient or user harm? no.Was there a significant delay? no.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/23/2026.D4 batch#: unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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 information was requested, and the following was obtained: was the firing sequence started but not completed? if yes: yes.Did the device deliver any staples? no.If yes, were the staples formed properly? na.What was the appearance of the deployed staples (b-formed, malformed, goal post/legs straight)? na.If yes, was the staple line complete? na.Was the backlight lit? no.Were there two complete tissue donuts? yes.Was it a partial cut? yes.If so what was cut partially, washer or tissue? tissue.If yes/no, was there any issue with the cut? yes.Was the device locked on tissue with the anvil closed? yes.If yes, what steps were taken to open the anvil? 2 full rotations counter clock-wise.If the anvil could not be opened, how was the device removed? na.Did the surgeon turn the rotation knob full revolutions as stated in the ifu? yes.Was the device difficult to close? no.Was there adjusting knob issues? no.Did the anvil detach? yes.Did indicator come into orange range? yes.Were there excessive tissue between the anvil and the deck? no.Did the surgeon wait the 15 seconds to fire the device? yes.

• 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: 50867272
• Report Number: 3005075853-2026-07890
• Device Sequence Number: 9223482
• Product Code: GDW
• UDI-Device Identifier: 10705036003458
• UDI-Public: (01)10705036003458(17)291031(10)362D37
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial

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: CDH25B
• Device Lot Number: 362D37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2024
• 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