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	Seroma (2069); Perforation of Vessels (2135); Unspecified Tissue Injury (4559); Insufficient Information (4580)
Date of Event	10/31/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: kim ts, kim kh, an ch, kim js.Single center experiences of needlescopic grasper assisted single incision laparoscopic cholecystectomy for gallbladder benign disease: comparison with conventional 3-port laparoscopic cholecystectomy.Ann surg treat res.2016 nov;91(5):233-238.Doi: 10.4174/astr.2016.91.5.233.Epub 2016 oct 31.Pmid: 27847795; pmcid: pmc5107417.The aim of the study is to introduce our technique needlescopic grasper assisted silc (nsilc) and evaluate the safety and feasibility of this technique compared with the conventional laparoscopic cholecystectomy (clc).From october 2011 to december 2012, 485 patients who underwent laparoscopic cholecystectomy for acute and chronic cholecystitis at uijeongbu st.Mary's hospital, the catholic university of korea were included in this study.Clc was performed in 252 patients and needlescopic assisted single nsilc was performed in 233 patients.Nsilcs were performed routinely through the sils port (covidien, dublin, ireland) with a snake liver retractor to push up the hepatic hilum in the cephalad direction; and endopath electrosurgery probe plus system (ethicon, somerville, nj, usa) composed of suction, irrigation unit, and hook electrode for meticulous dissection.Intraoperative complications occurred in 4 patients (bile duct injury 2, vascular injury 2) who underwent clc and 3 patients (bile duct injury 1, vascular injury 2) who underwent nsilc.¿ reported complications include: probe plus system (ethicon), bile spillage (n=24,) treatment: not reported.Bile duct injury (n=1), treatment: not reported.Vascular injury (n=2), treatment: not reported.Port site seroma (n=22), treatment: not reported.Conversion to open surgery (n=4), treatment: open surgery.In conclusion, the results of our study demonstrate that nsilc is a safe and feasible technique with similar outcome to that of clc not only in selective patients but also in patients with acute attacks of cholecystitis and other difficult factors such as obesity, previous operation, and so on.Therefore, this technique can be an alternative to standard laparoscopic chole cystectomy and a training module for beginners of silc due to its technical similarity to clc.However, more high-powered randomized control studies are required to validate these results.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/6/2026.B3: publication year of 2016.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.

• 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: 24793095
• Report Number: 3005075853-2026-02554
• Device Sequence Number: 15884653
• Product Code: GCJ
• 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): 04/06/2026

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: 03/18/2026
• Initial Report FDA Received Date: 04/06/2026
• 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