MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. N/A; STAPLE, IMPLANTABLE

Catalog Number	CDH25A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Obstruction/Occlusion (2422)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) date sent: 4/9/2026 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.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.Does the author/surgeon believe that the ethicon devices mentioned in this article caused/contributed to the reported events in the article? 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: tsujimura k, nakauchi m, hiro j, ito a, chikaishi y, kobayashi y, kamishima m, inaguma g, omura y, cheong y, kumamoto t, masumori k, hanai t, uyama i, suda k, otsuka k.Comparison of short-term outcomes for robotic rectal surgery between the hinotori¿ surgical robot system and da vinci surgical system: a single-center retrospective study using propensity score matching analysis.Surg endosc.2025 jun;39(6):3993-4005.Doi: 10.1007/s00464-025-11766-6.Epub 2025 may 2.Pmid: 40316750.The aim of this study is to report our initial surgical experiences with robotic surgery using hinotori for rectal cancer and its feasibility and safety comparing with da vinci.Between november 2022 and november 2023, a total of 38 and 96 patients with rectal cancer underwent robotic surgery using hinotori and da vinci, respectively.The median age was 69.5 years in the hinotori group and 69 years in the da vinci group.More than half of patients were male (hinotori: 57.9% da vinci: 60.5%).In hinotori the ethicon device was used in: after completion of mobilization of the rectum and its devascularization, if necessary, the rectum was transected using a linear stapler (powered echelon flex: ethicon inc., somerville, nj, us) through the port of the third arm, and after icg, end-to-end anastomosis was performed with the double-stapling technique using a circular stapler (cdh 25 or 29: ethicon inc., somerville, nj, us) in the conventional laparoscopic fashion.Reported complications are linear stapler (powered echelon flex: ethicon endo surgery) postoperative complications of clavien¿dindo (cd) grade = iiia were observed (n=3; 7.9%) treatment: not provided.Postoperative complications of clavien¿dindo (cd) grade = ii (n=6; 15.8%) treatment: not provided.Paralytic ileus of cd grade ii (n=3; 11.5%) treatment: not provided.Anastomotic leakage of cd grade iiib (n=1; 3.8%) treatment: not provided.Circular stapler (cdh 25 or 29: ethicon endo surgery) postoperative complications of clavien¿dindo (cd) grade = iiia were observed (n=3; 7.9%) treatment: not provided.Postoperative complications of clavien¿dindo (cd) grade = ii (n=6; 15.8%) treatment: not provided.Paralytic ileus of cd grade ii (n=3; 11.5%) treatment: not provided.Anastomotic leakage of cd grade iiib (n=1; 3.8%) treatment: not provided.In conclusion, our findings support that robotic surgery for rectal cancer using hinotori is as safe as surgery performed using the da vinci system.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/22/2026.Additional information was requested and the following was obtained: no further information will be provided because we can¿t get any additional information from the author.

• Brand Name: N/A
• 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: 24835774
• Report Number: 3005075853-2026-02715
• Device Sequence Number: 16059969
• Product Code: GDW
• UDI-Device Identifier: 10705036003458
• UDI-Public: 10705036003458
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: CDH25A
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 04/22/2026
• 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: Required Intervention
• Patient Sex: Unknown