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

Model Number	FORCETRIAD
Medical Device Problem Codes	Energy Output Problem (1431); Intermittent Energy Output (4025)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: lf1837, blunt tip sealer divider lf1837 (lot#50350123x); vlls10gen, vlls10gen ls series vessel sealing gen (serial#: unknown).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 reporter, during a sleeve gastrectomy, the handpiece had no coagulation.The generator was changed from forcetriad to ls10 but the issue was not resolved.The operation time was extended for at least 5 to 10 minutes.The patient had bleeding and was resolved by using bipolar energy.The patient was not taking any medications and blood transfusion was not necessary.The patient is doing good.
Event or Problem Description
According to the reporter, in the middle of a sleeve gastrectomy, the handpiece had coagulation issue when used on normal sleeve intervention meso vessel.There was activation tone and end tone was heard but there no re-grasp alarm.Jaws were cleaned normally.Generator was changed from forcetriad to ls10 but issue was not resolved.Operation time was extended for at least 5 to 10 minutes.Patient had bleeding and was resolved by using bipolar energy.Patient was not taking any medications and blood transfusion was not necessary.Patient is doing good.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 (fdd).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: 21960534
• Report Number: 1717344-2025-00640
• Device Sequence Number: 9188885
• Product Code: GEI
• UDI-Device Identifier: 10884524001531
• UDI-Public: 10884524001531
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/07/2025
• 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: PLEASE SEE NOTE ON H11.
• Patient Sex: Unknown