BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 23510567 · Received November 10, 2025

    Report

    Report Number
    3026612481-2025-00022
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    August 18, 2025
    Report Date
    November 18, 2025
    Manufacturer
    COVIDIEN
    Product Code
    BWA
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: VLFT10GEN, VLFT10GEN FT SERIES ENERGY PLATFORMX1 (SERIAL#(B)(6)); E6009, E6009 BIP FOOTSW X1 (LOT#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. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H6 ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, FLAME AND SMOKE WERE OBSERVED ON THE CORD CONNECTED TO THE MONOPOLAR 1 UNIVERSAL RECEPTACLE. THE CORD WAS BURNED AND BROKEN. THE UNIT'S CAUTERY SETTINGS WERE AS FOLLOWS: VALLEYLAB CAUTERY CUT 0 COAG 30. THE CORD USED WAS A NON-MEDTRONIC MANUFACTURED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2581266 VALLEYLAB UNIT, ELECTROSURGICAL AND COAGULATION, WITH ACCESSORIES BWA COVIDIEN E6008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PLEASE SEE NOTE ON H11.