BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA M320 W12

    MDR report key: 15071294 · Received July 21, 2022

    Report

    Report Number
    3003974370-2022-00013
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    July 11, 2022
    Report Date
    October 28, 2022
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 0

    THIS IS A FINAL REPORT. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE BROKEN LEICA M320 F12 FOOT BEARING IS A MECHANICAL MISUSE OF THE DEVICE BY APPLYING EXCESSIVE FORCE. THE MATERIAL EXAMINATION REVEALED THAT THE FOOT BEARING BROKE DUE TO SUDDEN OVERLOADING (DUCTILE FORCED FRACTURES). A DESIGN REVIEW REVEALED THAT THE SUBASSEMBLY IS DESIGNED WITH A SAFETY FACTOR OF 6 RELATED TO ITS NOMINAL LOAD. THERE IS NO DESIGN PROBLEM AND NO INDICATION OF AN ADVERSE TREND. IT CAN BE CONCLUDED THAT THE MALFUNCTION OCCURRED DUE TO A USER ERROR. THE DEFECTIVE SWING ARM WAS REPLACED BY A NEW ONE.

    Description of Event or Problem · 0

    LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM GERMANY STATING THAT THE SWING ARM OF THE M320 W12 FELL DOWN WHEN POSITIONING THE MICROSCOPE FROM THE PARK POSITION TO THE WORKING POSITION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241409 LEICA M320 W12 SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG M320 W12

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown