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

Model Number	FORCETRIAD
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a procedure, the unit had a sealing inadequate/partial (with evidence of energy delivery and end tones heard).The seal showed evidence of energy delivery, and there was a bleeding after cutting.The tissue/vessel being sealed was approximately 3mm.
Additional Manufacturer Narrative
Concomitant medical products: lf1944, jaw lap lf1944 ligasure maryland 44 cm, (lot #40520237x) lf1944, jaw lap lf1944 ligasure maryland 44 cm, (lot #31940025x).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 reportmedtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during the laparoscopic sleeve gastrectomy procedure, the device had a sealing that was inadequate or partial (with evidence of energy delivery and end tones heard).The seal showed evidence of energy delivery, and there was bleeding after cutting.The tissue or vessel being sealed was approximately three mm.There was no error message.No blood transfusions were performed.The completion of the procedure was delayed but it was done by switching to another generator.
Additional Manufacturer Narrative
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 the laparoscopic sleeve gastrectomy procedure, the device had a sealing that was inadequate or partial (with evidence of energy delivery and end tones heard).The seal showed evidence of energy delivery, and there was bleeding after cutting.The tissue or vessel being sealed is approximately 3 mm.There was no error message.No blood transfusions were performed.This incident did not cause the procedure to be extended by more than 30 minutes.There were post op issues.The completion of the procedure was delayed but it was done by switching to another generator.
Additional Manufacturer Narrative
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: 19711050
• Report Number: 1717344-2024-01453
• Device Sequence Number: 20960609
• Product Code: GEI
• UDI-Device Identifier: 10884524001531
• UDI-Public: 10884524001531
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup,Followup
• Report Date (Section B): 07/22/2024

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: 06/13/2024
• Supplement Date Received by Manufacturer: 07/01/2024; 07/11/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 07/15/2024; 07/22/2024
• 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: SEE H11
• Patient Sex: Unknown