BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENACURE 1470 PRO

    MDR report key: 19508093 · Received June 11, 2024

    Report

    Report Number
    3004378299-2024-00005
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    May 23, 2024
    Report Date
    June 11, 2024
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    UDI-DI
    08033945938925
    PMA / PMN Number
    K181632
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS INSUFFICIENT INFORMATION AT THIS TIME TO ADEQUATELY EVALUATE THE EVENT. THE ADVERSE EVENT DESCRIBED SEEMS TO HAVE BEEN PREDICTED AND INCLUDED IN THE INSTRUCTION MANUAL OF THE DEVICE. IT WOULD BE APPROPRIATE TO CARRY OUT FURTHER INVESTIGATIONS IN ORDER TO EXCLUDE THE CORRELATION OF A MACHINE MALFUNCTION WITH THE EVENT THAT OCCURRED. HOWEVER, IT IS DIFFICULT AT THIS TIME TO DETERMINE WHETHER THERE WERE ERRORS AT THE LEVEL OF CLINICAL PROCEDURE, MACHINE SETTING, AS NO DETAILS OF THE PROCEDURES PERFORMED WERE PROVIDED. WE ARE CURRENTLY IN CONTACT WITH THE COMPLAINANT TO GATHER ADDITIONAL DATA.

    Description of Event or Problem · 0

    AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A VENACURE 1470 PRO LASER. THE END USER REPORTED THAT THEY RECENTLY HAD SEVERAL PATIENT HAVE EHITS {ENDOTHERMAL HEAT-INDUCED THROMBOSIS} DURING THEIR 1 WEEK FOLLOW UPS POST EVLT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859437 VENACURE 1470 PRO SURGICAL LASER GEX QUANTA SYSTEM S.P.A. 08033945938925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown