MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD 23MM CURVED CIRCULAR, 18CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number	CDH23P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a total gastrectomy, the green check mark illuminated when the battery was inserted.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent 4/1/2025.D4 batch #555c18.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the cdh23p device arrived with no apparent damage.Only anvil half washer was received and the device was fully loaded with staples, indicating that the device had not been fired.However, when the test battery was installed the green checkmark illuminated indicated that the device was not reset.Due to staples present on the device is possible that the returned anvil does not belong to the returned device since anvils are interchangeable with the same product.No functional test was performed due to the condition of the device.The device was disassembled to verify the condition of the internal components and the cam was rotated so that it was touching the stop switch actuator this defect has been correlated to a manufacturing process.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon endo surgery¿s quality system.A manufacturing record evaluation was performed for the finished device batch number 555c18, and no non-conformances related to the reported complaint condition were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: could you please confirm the event/procedure date?.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/21/2025.Additional information was requested, and the following was obtained: could you please confirm the event/procedure date? the event date: 21 february 2025./procedure date: (b)(6) 2025.

• Brand Name: PWRD 23MM CURVED CIRCULAR, 18CM SHAFT
• 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: 21738184
• Report Number: 3005075853-2025-02415
• Device Sequence Number: 13012242
• Product Code: GDW
• UDI-Device Identifier: 10705036015369
• UDI-Public: (01)10705036015369(17)261031(10)C9DG2U
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163523
• 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): 04/21/2025

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: CDH23P
• Device Lot Number: C9DG2U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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