MAUDE Adverse Event Report: COVIDIEN VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VLFT10GEN
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: lf1837, blunt tip sealer divider lf1837 (lot#: 43090191x).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
It was reported that during a gastric sleeve procedure, the blunt tip device was used in combination with the generator.The sealing quality was poor at multiple sites, with persistent bleeding and oozing observed after sealing and cutting.Most seals were not adequate, despite evidence of energy delivery and end tones being heard.The surgeon had to spend considerable time re-sealing tissues, which significantly extended the surgical time and increased the workload.The tissue being sealed was the greater omentum, with an approximate thickness of 5mm.The procedure was completed using the same handle.
Additional Manufacturer Narrative
Additional information: g3, b5.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
It was reported that during a gastric sleeve procedure, the ligasure¿ blunt tip device was used in combination with the ft10 generator.The sealing quality was poor at multiple sites, with persistent bleeding and oozing of approximately 300¿400 ml observed after sealing and cutting.Most seals were not adequate, despite evidence of energy delivery and end tones being heard.No re-grasp alert or error message occurred during the procedure.The device was cleaned twice during the case.Although no blood transfusion was necessary, the surgeon had to spend considerable time re-sealing tissues, which significantly extended the surgical time by approximately 30 minutes and increased the overall workload.The tissue being sealed was the greater omentum, with an approximate thickness of 5 mm.The procedure was completed using the same ligasure handle.
Event or Problem Description
It was reported that during a gastric sleeve procedure, the device was used in combination with the generator.The sealing quality was poor at multiple sites, with persistent bleeding and oozing of approximately 300¿400 ml observed after sealing and cutting.There were 11 good seals completed when most seals were not adequate, despite evidence of energy delivery and end tones being heard.No re-grasp alert or error message occurred during the procedure.The device was cleaned twice during the case.Although no blood transfusion was necessary, the surgeon had to spend considerable time re-sealing the 2-4 mm short gastric artery, which significantly extended the surgical time by approximately 30 minutes and increased the overall workload.The tissue being sealed was the greater omentum, with an approximate thickness of 5 mm.The procedure was completed using the same handle.
Additional Manufacturer Narrative
Additional information: b5, g3.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: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23052783
• Report Number: 1717344-2025-01175
• Device Sequence Number: 8582151
• Product Code: GEI
• UDI-Device Identifier: 10884521548350
• UDI-Public: 10884521548350
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K151649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2025

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: VLFT10GEN
• Device Catalogue Number: VLFT10GEN
• 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: 08/24/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 10/22/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 09/23/2025; 10/24/2025
• 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
• Patient Sex: Female