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 Code	Insufficient Information (4580)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 05/08/2026.B3: publication year of 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 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: cho cw, rhu j, kim ks, oh n, choi gs.Cognitive task analysis-based education and expansion of pure laparoscopic donor hepatectomy for the next generation: a comparative study of surgical outcomes between expert and fellowship-trained surgeons.Surg endosc.2026 feb;40(2):1694-1703.Doi: 10.1007/s00464-025-12466-x.Epub 2026 jan 26.Pmid: 41586911.This study aimed to evaluate the effectiveness of cognitive task analysis (cta)-based training in developing technical skills and a professional mindset to enable fellowship-trained surgeons (ftss) to perform pldh for aldlt and to compare surgical outcomes with those of expert surgeons.From december 2016 to december 2023, a total of 55 cases of pldh and aldlt performed by three ftss were compared with those from 462 cases performed by one expert surgeon.There were (n=55) in fts group, with 34 (61.8%)males and 21 (38.2%) females with the mean age of 38±13 years old, on the other hand, there were (n=462) in expert group with 259 (56.15) males and 203 (43.9%) females with the mean age of 37±14 years old.Eps endopath¿ electrosurgery probe plus¿ ii system was used for executing tasks of pldrh using the diamond-core port system.The mean duration follow-up was not reported.Reported complications: eps endopath¿ electrosurgery probe plus¿ ii system (ethicon endo surgery): (n=25) hepatic artery complication treatment: not reported (n=24) portal vein complication treatment: not reported (n=8) hepatic vein complication treatment: not reported (n=53) bile leakage treatment: not reported (n= 141) bile duct stricture treatment: not reported (n=11) grade i/ii clavien¿dindo classification treatment: not reported (n=104) grade iiia/iiib clavien¿dindo classification treatment: not reported (n=4) grade iv clavien¿dindo classification treatment: not reported (n=16) grade v clavien¿dindo classification treatment: not reported eps endopath¿ electrosurgery probe plus¿ ii system (ethicon endo surgery): (n=5) death in the fts group, five recipients (9.1%) died within 90 days after transplantation.Treatment: among these, two deaths were caused by septic shock due to postoperative infections, two occurred in jehovah¿s witnesses who developed postoperative bleeding but could not receive blood transfusions, and one resulted from hepatic vein outflow insufficiency leading to graft failure.In conclusion, cta-based education for llr has shown to be an effective strategy for enabling ftss to perform complex procedures such as pldh.This approach is not only beneficial for enhancing surgical proficiency among ftss but also serves as a valuable framework for expanding the application of minimally invasive techniques in major donor hepatectomies for aldlt.

• 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: 25129992
• Report Number: 3005075853-2026-03518
• Device Sequence Number: 21137088
• Product Code: GEI
• UDI-Device Identifier: 10705036012443
• UDI-Public: 10705036012443
• 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