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

Model Number	FORCETRIAD
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during laparoscopic radical gastrectomy, at the beginning, the device was unable to coagulate the mesenteric blood vessel although the hardware screen showed the circle was completed.Vessel thickness was 2-3 millimeters.Energy delivery was noted and no error tones were heard.Tried several times to change the lots of device, generators, and even power charging lines but the effect was the same.There was a blood loss of 20 milliliters; no blood transfusion was required.The jaws were clean and fresh, without eschar.The procedure was not completed in a very pleasant mood.The generator has been updated to software 4.0.
Additional Manufacturer Narrative
D10 concomitant product: lf1937, jaw lap lf1937 ligasure maryland 37cm (lot#22860134x); vlft10gen, vlft10gen ft series energy platformx1 (serial#t0d41094dx); lf1937, jaw lap lf1937 ligasure maryland 37cm (lot#22000104x); lf1937, jaw lap lf1937 ligasure maryland 37cm (lot#30480126x); vlft10gen, vlft10gen ft series energy platformx1 (serial#unknown); vlls10ge, 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.

• Brand Name: FORCETRIAD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• 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: 20892660
• Report Number: 1717344-2024-02194
• Device Sequence Number: 21042652
• Product Code: GEI
• UDI-Device Identifier: 10884524001531
• UDI-Public: 10884524001531
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2024

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: 11/19/2024
• Initial Report FDA Received Date: 12/10/2024
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 120 KG