BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VECTUS

    MDR report key: 8201418 · Received December 27, 2018

    Report

    Report Number
    1222993-2018-00033
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    November 29, 2018
    Report Date
    December 27, 2018
    Manufacturer
    CYNOSURE INC.
    Product Code
    GEX
    PMA / PMN Number
    K120622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT THE DEVICE'S DISPLAY SCREEN HAD BLANKED (WHITE SCREEN), WHICH THEN MADE THE UNIT INOPERABLE. TECHNICIAN ADDRESSED THE CUSTOMER'S ISSUE BY REPLACING THE HANDPIECE. ROUTINE MAINTENANCE (CLEANING, CALIBRATIONS, OUTPUT VERIFICATION CHECKS) WAS PERFORMED ON THE DEVICE. THE AFFECTED HANDPIECE WAS THEN EVALUATED BY A CYNOSURE IN-HOUSE TECHNICIAN WHO ENCOUNTERED A SYSTEM ERROR MESSAGE WHICH INDICATED OF A COMPONENT FAILURE WITH THE LIGHT ENGINE ASSEMBLY. THE APPEARANCE OF THIS ERROR MESSAGE IS AN EXPECTED SYSTEM RESPONSE THAT INFORMS THE USER OF THE HANDPIECE BEING INOPERABLE/NEEDING REPAIR. THE TECHNICIAN RESOLVED THE ERROR BY REPLACING THE AFFECTED COMPONENT. FROM THE INVESTIGATION, THE ROOT CAUSE FOR THE ALLEGED MISFIRING COULD NOT BE CONFIRMED IN THIS INCIDENT. THERE WAS NO PATIENT INJURY INVOLVED IN THIS INCIDENT. THIS EVENT IS AN ARO (ACCIDENTAL RADIATION OCCURRENCE) BECAUSE OF THE ALLEGED UNINTENDED DISCHARGE OF LASER ENERGY. THEREFORE, THIS IS A REPORTABLE EVENT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED OF AN UNINTENDED DISCHARGE OF ENERGY FROM DEVICE'S HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040945 VECTUS VECTUS GEX CYNOSURE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1