BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 20163006 · Received September 6, 2024

    Report

    Report Number
    1717344-2024-01771
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    June 24, 2024
    Report Date
    September 6, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    BWA
    UDI-DI
    10884521766662
    PMA / PMN Number
    K874794
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343983 VALLEYLAB UNIT, ELECTROSURGICAL AND COAGULATION, WITH ACCESSORIES BWA COVIDIEN MFG DC BOULDER E6008L 399764 10884521766662

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11