MAUDE Adverse Event Report: Covidien VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	VLFT10GEN
Medical Device Problem Codes	Self-Activation or Keying (1557); High Readings (2459); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that high output was observed when testing cross-coupling.During retesting, mono 1 to mono 2 coag spray at 120 w measured 222 ma on two tests.The test setup was verified, point-of-care validation was completed, and troubleshooting steps were provided.There was no patient involved.
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: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): Covidien; 6044 longbow court; boulder CO 80301 -329
• Manufacturer (Section G): Covidien; 6044 longbow court; boulder CO 80301 -329
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50728552
• Report Number: 1717344-2026-01256
• Device Sequence Number: 16107268
• Product Code: GEI
• UDI-Device Identifier: 10884521516328
• UDI-Public: (01)10884521516328(11)220831
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: 08/21/2026
• Initial Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 08/31/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown