MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; UNIT, ELECTROSURGICAL AND COAGULATION, WITH ACCESSORIES

Model Number	E6008L
Medical Device Problem Codes	Energy Output Problem (1431); Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: vlft10gen, vlft10gen ft series energy platformx1 (sn: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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during testing, when cut was activated using the pedal, the display showed coagulation and vice versa.Customer confirmed it was the foot switch at fault by cross checking with another ft10 generator.There was no patient involvement.

• Brand Name: VALLEYLAB
• Common Device Name: UNIT, ELECTROSURGICAL AND COAGULATION, WITH 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: 20163006
• Report Number: 1717344-2024-01771
• Device Sequence Number: 15279139
• Product Code: BWA
• UDI-Device Identifier: 10884521766662
• UDI-Public: 10884521766662
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K874794
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2024

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: E6008L
• Device Catalogue Number: E6008L
• Device Lot Number: 399764
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/06/2024
• Date Device Manufactured: 04/10/2023
• 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