BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA M320 W12

    MDR report key: 4620440 · Received March 18, 2015

    Report

    Report Number
    3003974370-2015-00001
    Event Type
    Malfunction
    Date Received
    March 18, 2015
    Date of Event
    February 6, 2014
    Report Date
    February 6, 2014
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR REPORT NUMBER OF THE INITIAL REPORT SUBMITTED ON DATE 02/20/2015 WAS ERRONEOUSLY SHOWN AS 3003974370-2015-00016. THE MFR REPORT NUMBER FOR THE EVENT AT DR. (B)(6) FACILITY IS IDENTIFIED AS 3003974370-2015-00001 AND HAD BEEN CORRECTED IN SECTION "MFT REPORT#". THIS IS A FINAL REPORT. AN INVESTIGATION ON THE AFFECTED PART OF THE SURGICAL MICROSCOPE (PARALLELOGRAM) WAS CONDUCTED BY THE SPECIFICATION DEVELOPER. VISUAL INSPECTION AND FUNCTIONAL EVAL OF THE AFFECTED COMPONENT WERE PERFORMED. THE MALFUNCTION WAS NOT REPRODUCIBLE TO RESULT IN THE SAME DAMAGES OF SCREWS AS REPORTED. IT WAS FOUND THAT THE ROOT CAUSE IS THAT THE SCREWS OF A COMPONENT WERE NOT PROPERLY TIGHTENED DUE TO HUMAN ERROR AT THE SUPPLIER'S MFG SITE BASED ON INVESTIGATION AT THIS SUPPLIER. THERE ARE NO INDICATIONS THAT THE PROBLEM IS SYSTEMATIC. BASED ON THE RESULTS, THE PROBABILITY OF OCCURRENCE IS REMOTE. THEREFORE THE INCIDENT CAN BE CONSIDERED AS AN ISOLATED EVENT.

    Description of Event or Problem · 1

    (B)(4). ON 02/06/2015, LEICA MICROSYSTEMS RECEIVED A COMPLAINT STATING THAT THE SWING ARM OF THE LEICA M320 W12 SURGICAL MICROSCOPE FELL TO THE LOWEST ARM POSITION BESIDE THE PT. THE SURGEON WAS ABLE TO HOLD ON TO ONE OF THE EYE PIECES TO STOP THE FALL. IT WAS REPORTED THAT THERE WAS NO INJURY TO PT OR USER. THE SURGICAL MICROSCOPE IS OUT OF SERVICE AND THE AFFECTED PART IS BEING SHIPPED TO MANUFACTURER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183669 LEICA M320 W12 MICROSCOPE, SURGICAL EPT LEICA MICROSYSTEMS (SCHWEIZ) AG M320 W12

    Patients

    Seq Age Sex Outcome Treatment
    1