MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD 25MM CURVED CIRCULAR, 18CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number	CDH25P
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Stenosis (2263); Obstruction/Occlusion (2422)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 1/21/2026 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.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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
This complaint is from a literature source.The following literature cite has been reviewed: saito a, otsuka k, goto s, ariyoshi t, yamashita t, motegi k, komoto m, kishimoto y, murakami m, aoki t.Comparison of anastomotic stricture rates between 23- and 25-mm powered circular staplers in cervical esophagogastric anastomosis: a propensity-matched study.Esophagus.2025 dec 22.Doi: 10.1007/s10388-025-01171-2.Epub ahead of print.This study aimed to compare stenosis rates between newly introduced 23- and 25-mm powered circular stapler (css) in cervical esophagogastric anastomosis.From (b)(6) 2022 to (b)(6) 2024, 126 patients who underwent thoracoscopic mckeown esophagectomy with retrosternal gastric conduit reconstruction were retrospectively analyzed.They were categorized into the 23 mm (n = 52) and 25-mm (n = 74) cs groups.Reported complications include the incidence of anastomotic stricture was 18.0% (7 cases) and 12.8% (5 cases) in the 23- and 25-mm cs groups, respectively.The incidence of anastomotic leakage and the leakage location revealed no significant differences between the two groups.In conclusion, 23- and 25-mm powered css achieved comparable anastomotic stricture rates in cervical esophagogastric anastomosis during mckeown esophagectomy.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/23/2026.Corrected data: h6 (health effect - clinical code).

• Brand Name: PWRD 25MM 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: 24137099
• Report Number: 3005075853-2026-00640
• Device Sequence Number: 5430550
• 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,Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CDH25P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown