BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA M320 F12

    MDR report key: 9003637 · Received September 12, 2019

    Report

    Report Number
    3003974370-2019-00008
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Date of Event
    August 19, 2019
    Report Date
    November 28, 2019
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE IDENTIFIED ROOT CAUSE FOR THE BROKEN FOOT BEARING OF THE LEICA M320 F12 IS A MECHANICAL MISUSE OF THE DEVICE BY APPLYING EXCESSIVE FORCE. THE MATERIAL INVESTIGATION 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. A REVIEW OF THE COMPLAINT DATABANK SHOWED NO (0) SIMILAR CASES OF BROKEN FOOT BEARINGS AND NO INDICATIONS FOR A SYSTEMIC ISSUE. THEREFORE, IT CAN BE CONCLUDED THAT THE MALFUNCTION OCCURED DUE TO SUDDEN EXCESSIVE FORCE APPLIED TO THE SYSTEM AND CAN BE CONSIDERED AN ISOLATED EVENT. NOTE: THE ISSUE WAS RESOLVED BY REPLACEMENT OF THE DEFECTIVE SWING ARM.

    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

    ON (B)(6) 2019, LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM (B)(4) STATING THAT REAR PIVOT JOINT OF A LEICA M320 PARALLELOGRAM BROKE. THE LEICA M320 PARALLELOGRAM DROPPED DOWN DURING A PROCEDURE (ELECTROLYSIS AT AN ESTHETICIAN'S OFFICE). THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806280 LEICA M320 F12 SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG

    Patients

    Seq Age Sex Outcome Treatment
    1