MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX 60 LONG; STAPLE, IMPLANTABLE

Catalog Number	LONG60A
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)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) date sent: 8/13/2025 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.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: ishiyama y, hirano y, sasaki m, akuta s, yoshizawa m, yamato m, nakanishi a, minagawa y, hayashi h, fujii t, okazaki n, ishii t, hiranuma c.End-to-end anastomosis with echelon endopath¿ staple line reinforcement for right-sided colon cancer: safety and feasibility.In vivo.2025 may-jun;39(3):1573-1579.Doi: 10.21873/invivo.13957.Pmid: 40294993; pmcid: pmc12041969.The aim of this retrospective study aimed to evaluate the efficacy and safety of feea with slr compared to conventional feea in elective right-sided colon cancer surgery.Between february 2019 and december 2022, a total of 159 (surgical technique group; 90 and non surgical technique group; 69) consecutive patients who underwent elective surgery for right-sided colon cancer.Echelon flex (ees) was used to dissect and anastomosed the ileum and colon in surgical technique (slr group), while it was used to closed the common hole in non-slr.While echelon endopath (ees) was used to closed the common hole.Reported complications: echelon flex (ees), echelon endopath (ees, slr group (n=90), non slr group (n=69).Slr group (n=90), postoperative anastomotic bleeding (n=2), treatment: not provided.Non slr group (n=69), postoperative anastomotic bleeding (n=2), treatment:.One case in the non-slr group required a blood transfusion.Anastomotic leakage (n=1), treatment: not provided.In conclusion, slr represents a safe and effective adjunctive technique for feea in right-sided colon cancer surgery.Further validation through larger prospective studies is warranted to confirm these preliminary results.

• Brand Name: ECHELON FLEX 60 LONG
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 22797478
• Report Number: 3005075853-2025-06434
• Device Sequence Number: 12922441
• Product Code: GDW
• UDI-Device Identifier: 10705036002444
• UDI-Public: 10705036002444
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081146
• 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
• Report Date (Section B): 08/13/2025

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: LONG60A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/13/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ECR60B (X2); UNK_ECHELON ENDOPATH STAPLE LINE REINFORCEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown