MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	SEP6000
Medical Device Problem Codes	Fire (1245); Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: vlft10gen, vlft10gen ft series energy platformx1 (serial# (b)(6)).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 total hysterectomy and bilateral salpingo oophorectomy, a flame appeared at the tip of the diathermy pencil about the length of a pen.It had to be waved about and blown on to be put out.The hand piece was removed from the surgical site, a new one was opened, and the surgery was completed without further issues.No patient complications have been reported as a result of this event.
Event or Problem Description
It was reported that during a total hysterectomy and bilateral salpingo oophorectomy, a flame appeared at the tip of the diathermy pencil about the length of a pen.It had to be waved about and blown on to be put out.The surgeon had already used the diathermy handpiece for a short period with no issue, but on using it again, a small flame appeared at the tip.The hand piece was removed from the surgical site, a new one was opened, and the surgery was completed without further issues.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: b5, d3 (mfr name and address), d4 (udi#), g3, h6 (fdd) 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): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette,co MN 55112
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette,co MN 55112
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22337394
• Report Number: 2182208-2025-03099
• Device Sequence Number: 9126183
• Product Code: GEI
• UDI-Device Identifier: 10884521750913
• UDI-Public: (01)10884521750913(17)291231(10)2312057X
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K182772
• 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
• Report Date (Section B): 08/27/2025

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: SEP6000
• Device Catalogue Number: SEP6000
• Device Lot Number: 2312057X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 63 KG