BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA MICROSYSTEMS

    MDR report key: 5903051 · Received August 25, 2016

    Report

    Report Number
    3003974370-2016-00009
    Event Type
    Malfunction
    Date Received
    August 25, 2016
    Date of Event
    August 1, 2016
    Report Date
    February 6, 2020
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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 THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW-UP REPORT. VISUAL INSPECTION WAS PERFORMED BY THE RESPONSIBLE LEICA FIELD SERVICE ENGINEER ON SITE. THE RETURN OF THE DEFECTIVE PART OF THE AFFECTED DEVICE HAS BEEN REQUESTED, HOWEVER IT HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. THE INVESTIGATION WILL BE PERFORMED AS SOON AS THE DEFECTIVE PART HAS BEEN RECEIVED BY THE MANUFACTURER. THE FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. PLEASE NOTE: THIS IS A RESUBMISSION OF THE MDR REPORT - 3003974370-2016-00009 FOLLOW-UP # 01 WITH THE CORRECT MANUFACTURER NUMBER AS REQUESTED BY THE US-FDA THROUGH AN EMAIL.

    Additional Manufacturer Narrative · 1

    BASED ON THE RESULTS OF THE INITIAL INVESTIGATION, THE DEVICE THAT MALFUNCTIONED WAS THE HDMD (SERIAL NUMBER: (B)(4)), WHICH WAS MANUFACTURED BY MED X CHANGE, INC. (B)(4), AND NOT LEICA'S SURGICAL MICROSCOPE. THE INITIAL COMPLAINT INFORMATION WAS PROVIDED TO MED X CHANGE, INC. ON (B)(4) 2016. THE AFFECTED DEVICE WAS RETURNED TO LEICA MICROSYSTEMS FROM THE END USER ON (B)(4) 2016. AFTER INITIAL INVESTIGATION ON THE AFFECTED DEVICE, IT WAS THEN SENT TO MED X CHANGE, INC. THE AFFECTED DEVICE WAS DELIVERED ON OCTOBER 19, 2016 AND AN ACKNOWLEDGMENT OF RECEIPT FROM MED X CHANGE, INC. WAS RECEIVED BY LEICA ON OCTOBER 20, 2016.

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY REPORTED MANUFACTURING SITE INFORMATION WAS INCORRECT AND THEREFORE THE CORRECT DATA OF THE MANUFACTURING SITE'S ADDRESS, FAX NUMBER AND EMAIL ADDRESS ARE BEING SUBMITTED.

    Description of Event or Problem · 1

    LEICA MICROSYSTEMS (B)(4) RECEIVED A COMPLAINT ON (B)(6) 2016 FROM USA STATING THAT A LEICA M525 OH4 SURGICAL MICROSCOPE CAUGHT FIRE AND ACCORDING TO THE UNIVERSITY BIO-MED, THE RECORDING SYSTEM (B)(4) MAY HAVE BEEN THE COMPONENT THAT CAUGHT FIRE AND CAUSED SMOKE TO APPEAR. THE OPERATING ROOM STAFF MOVED THE MICROSCOPE SYSTEM OUT OF THE FIELD AND USED ANOTHER MICROSCOPE TO PERFORM THE SURGERY. THERE WAS NO PATIENT/USER INJURY REPORTED AND NO FURTHER INFORMATION IS AS YET AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556180 LEICA MICROSYSTEMS LEICA M525 OH4 EPT LEICA MICROSYSTEMS (SCHWEIZ) AG M525 OH4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other