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

Catalog Number	CDH23P
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 2/6/2025.D4 batch # unk.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.No lot or batch number was provided therefore a device history could not be done.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 thoracoscopic esophagectomy, the device could not close after the anvil and the trocar were connected in the esophagus for cervical anastomosis.And also the anvil and the trocar could not separate, and cdh was removed by resection.Additional hand suture was performed to complete the case.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/10/2025.Additional event information ·were there any discomfort or abnormality before tightening the adjusting knob? (e.G., backlight did not turn on, etc.) 1 to 1.5 turned, but could not close.There was not other discomfort.·were there any changes in the procedure due to the shift to hand suture anastomosis?(e.G., open the chest, addition of a port hole, etc.) there was no change in the procedure.Only the reconstruction method was changed.·is there any problem with the patient's condition after the surgery? there are no problems with the patient's condition after the surgery.

• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 21326405
• Report Number: 3005075853-2025-01035
• Device Sequence Number: 18293622
• Product Code: GDW
• UDI-Device Identifier: 10705036015369
• UDI-Public: 10705036015369
• 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): 02/10/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 02/10/2025
• 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