BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA M720 OH5

    MDR report key: 2891319 · Received December 21, 2012

    Report

    Report Number
    3003974370-2012-00017
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 21, 2012
    Manufacturer
    LEICA MICROSYSTEMS SCHWEIZ AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. ACCORDING TO THE COMPLAINT REPORT, THE BRAKE IN THE Z AXIS AS WELL AS THE BRAKES IN THE AB AND C AXES OF LEICA M720 OH5 FAILED DURING INSTALLATION. FURTHER INVESTIGATION IS STILL BEING CONDUCTED BY THE MANUFACTURER. ONCE THE RESULTS OR NEW INFORMATION IS OBTAINED, A FOLLOW-UP/FINAL FORM FDA 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, LEICA MICROSYSTEM RECEIVED A COMPLAINT STATING THAT THE BRAKE IN THE Z AXIS AS WELL AS THE BRAKES IN THE AB, AND C AXES OF LEICA M720 OH5 FAILED DURING INSTALLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA M720 OH5 SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS SCHWEIZ AG M720 OH5

    Patients

    Seq Age Sex Outcome Treatment
    1