BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARVEO 8X

    MDR report key: 25067910 · Received May 4, 2026

    Report

    Report Number
    3003974370-2026-00003
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 4, 2026
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    UDI-DI
    07630802405906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM ITALY STATING THAT AN ARVEO 8X SWITCHED OFF DURING SURGERY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608420 ARVEO 8X SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG 10449213 07630802405906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown