MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCETRIAD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	FORCETRIAD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pleural Effusion (2010); Ascites (2596)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the literature, a retrospective study analyzed the outcomes of patients who underwent robotic distal gastrectomy with a single-port robotic platform for the treatment of gastric cancer between march 2023 and april 2024.It was noted that a ligasure device or competitor product was utilized intra-operatively to divide thick tissue and vessels.There were 20 patients included in the study and complications included pleural effusion and chyle ascites.No re-operation or mortality was reported; however, interventions and patient outcomes are unknown.
Additional Manufacturer Narrative
D10 concomitant products: unknown ligasure instrument - unknown ligasur, lot# unknown ayaka ito, masaya nakauchi, masahiro fujita, yusuke umeki,kazumitsu suzuki, akiko serizawa·shingo akimoto yusuke watanabe· tsuyoshi tanaka· susumu shibasaki· kazuki inaba· ichiro uyama, koichi suda1 initial clinical experiences of robotic distal gastrectomy for gastric cancer using the da vinci¿ sp system: a single-center retrospective study https://doi.Org/10.1007/s00423-025-03685-w medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the literature, a retrospective study analyzed the outcomes of patients who underwent robotic distal gastrectomy with a single-port robotic platform for the treatment of gastric cancer between march 2023 and april 2024.It was noted that a ligasure device or competitor product was utilized intra-operatively to divide thick tissue and vessels.There were 20 patients included in the study and complications included pleural effusion and chyle ascites.No re-operation or mortality was reported; however, interventions and patient outcomes are unknown.Additional information was received stating that adverse events mentioned within the article did not relate directly to medtronic devices/products.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 (rfr, fdd, fdp and imf) additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: FORCETRIAD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21893010
• Report Number: 1717344-2025-00586
• Device Sequence Number: 8387592
• Product Code: GEI
• UDI-Device Identifier: 10884524002903
• UDI-Public: 10884524002903
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110268
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: FORCETRIAD
• Device Catalogue Number: FORCETRIAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 04/27/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown