MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	EPH02
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Peritonitis (2252); Obstruction/Occlusion (2422); Insufficient Information (4580)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 5/8/2026.B3: publication year of 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 manufacturing 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 device caused or contributed to the patient complications mentioned in the article? if yes, please explain.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: ahn js, park j, ryoo sb, kim mj, park jw, jeong sy, park kj.Safety and efficacy of flexible articulated instrument (artisential®) in laparoscopic surgery for rectal cancer.Bmc surg.2025 may 2;25(1):192.Doi: 10.1186/s12893-025-02841-9.Pmid: 40312374; pmcid: pmc12046734.The aim of the study is to analyze the safety and efficacy of flexible articulated instruments in laparoscopic surgery for rectal cancer.The medical records of consecutive patients who underwent laparoscopic resection for rectal cancer performed by a single experienced surgeon between 2012 and 2022 were retrospectively analyzed.Finally, 93 patients were included in the study.The patients were divided into two groups based on the use of artisential® instrument (¿articulating group¿) or its non-use (¿straight group.The ¿straight group¿ used a conventional device: endopath® electrosurgery probe plus® ii system (eps02/eph02; ethicon co., oh, us).¿ reported complications include: endopath® electrosurgery probe plus® ii system wound complications (n=8) treatment: not reported intraperitoneal infection (n=4) treatment: not reported anastomotic leakage (n=1) treatment: not reported urinary complications (n=4) treatment: not reported postoperative ileus (n= 13) treatment: not reported in conclusion, this study demonstrated that flexible articulated instruments may reduce operative time during laparoscopic rectal cancer surgery without compromising oncologic outcomes, suggesting the enhanced efficacy of the device in dissecting challenging surgical planes during tme in laparoscopic rectal cancer surgery.However, because this was a single-institution study led by an experienced surgeon, further multicenter or prospective trials are necessary to confirm these results, verify the proper patient selection variables, and determine the specific technical features responsible for the observed reduction in operative time.

• Brand Name: ENDOPATH
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• 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: 25128335
• Report Number: 3005075853-2026-03517
• Device Sequence Number: 10694456
• Product Code: GEI
• UDI-Device Identifier: 10705036012467
• UDI-Public: 10705036012467
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K912492
• 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): 05/08/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: EPH02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/08/2026
• 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