BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARVEO

    MDR report key: 9150083 · Received October 3, 2019

    Report

    Report Number
    3003974370-2019-00012
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    September 16, 2019
    Report Date
    November 28, 2019
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED ON AN IN-HOUSE MICROSCOPE OF THE SAME TYPE AS THE AFFECTED FIELD UNIT. RESULTS REVEALED THAT THE DEVICE OPERATED WITHIN SPECIFICATION (VOLTAGE RANGE OF 120 V +/- 10%). HOWEVER, THE DEVICE FAILED WHEN THE VOLTAGE INPUT WAS LOWERED FURTHER (E.G. 106 V). THEREFORE, THE PROBLEM CAN BE TRACED TO THE A LOWERED POWER SUPPLY INPUT (E.G. POWER DIP EQUAL TO OR LOWER THAN 106 V) TO THE SURGICAL MICROSCOPE.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW-UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING INVESTIGATION.

    Description of Event or Problem · 1

    LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM USA STATING THAT AN ARVEO SHUT DOWN DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945610 ARVEO SURGIAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG

    Patients

    Seq Age Sex Outcome Treatment
    1