MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. RELOAD- CURVED CUTTER STAPLER; STAPLE, IMPLANTABLE

Catalog Number	CR40G
Medical Device Problem Codes	Unintended Ejection (1234); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent 10/13/2025 d4 batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.Additional information was requested, and the following was obtained: were there any patient consequences or adverse event (i.E.Prolonged hospitalization/infection/complication etc)? ans: no, patient is recovering well as per surgeon update on (b)(6).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 a hartman procedure, surgeons were placing the device on the sigmoid colon and compressed it well.After firing, they noticed that the tissue wasn't been cut but stapled.The surgeon had to transect the tissue with scissors, and re-enforced the staple line with suture.Surgeon told that the tissue wasn't too thick and compressible.There was no difficulty to close the handle but he noticed the reload was bit loose from the device.This device is re-used piece but with new reloads.

• Brand Name: RELOAD- CURVED CUTTER STAPLER
• 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; 3035526892
• MDR Report Key: 23278036
• Report Number: 3005075853-2025-07968
• Device Sequence Number: 14842877
• Product Code: GDW
• UDI-Device Identifier: 10705036001430
• UDI-Public: (01)10705036001430(17)261231(10)598A20
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K040038
• 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): 10/13/2025

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 Catalogue Number: CR40G
• Device Lot Number: 598A20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2022
• 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