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

Catalog Number	GLC80
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); Hemorrhage/Blood Loss/Bleeding (1888); Obstruction/Occlusion (2422)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 4/8/2026.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.This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.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: benshabat e, yuval jb, leibovitzh h, hirsch a, lahat g, kariv y, zemel m.Comparing perioperative outcomes of stapled versus handsewn kono-s anastomosis after ileocolonic resection for crohn's disease.Tech coloproctol.2025 oct 16;29(1):182.Doi: 10.1007/s10151-025-03219-y.Pmid: 41099860; pmcid: pmc12532619.The aim of the study is to compare the operative time and perio perative outcomes of stapled versus handsewn kono-s ileocolonic anastomosis in patients with cd.This was a single-center, observational cohort study.The study included all consecutive patients with a confirmed diagnosis of cd, who underwent an antimesenteric functional end-to-end kono-s anastomosis for restoring bowel continuity after icr at the tel aviv medical center from 11 july 2023 to 3 april 2025.25 patients underwent ileocolic resection with an antimesenteric functional end-to-end (kono-s) anastomosis.In total, 10 patients (40%) had a stapled kono-s anastomosis and 15 (60%) had a handsewn kono-s.The handsewn anastomosis was done as described in previous studies [6], whereas the stapled kono-s anastomosis was done with the same principles while using a gia¿ or echelon linear cutter¿ with 80 mm length, 3.8/1.5 mm (open/close) staples and 3.7/1.5 mm (open/close), respectively.¿ reported complications include: echelon linear cutter¿ (ees).Anastomotic leak (n=2).Treatment: treated with antibiotics.Post operative ileus (n=1) treatment: not reported.Postoperative intraluminal hemorrhage (n=2).Treatment: one patient required re admission, but none required transfusion.In conclusion, converting the functional end-to-end ileocolic anastomosis kono-s from handsewn to a stapled technique significantly reduces the operative time while lowering post operative crp levels and without compromising 30-day peri-operative outcomes.We believe that this allows standardization of the technique and shows feasibility and safety of the procedure.Further studies are needed to show advantages in endoscopic, clinical, and surgical recurrences.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 24822272
• Report Number: 3005075853-2026-02659
• Device Sequence Number: 9686679
• Product Code: GDW
• UDI-Device Identifier: 10705036030881
• UDI-Public: 10705036030881
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K223760
• 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
• Report Date (Section B): 04/08/2026

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: GLC80
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/08/2026
• 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