BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARVEO

    MDR report key: 9365643 · Received November 22, 2019

    Report

    Report Number
    3003974370-2019-00013
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    July 31, 2019
    Report Date
    November 22, 2019
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A COMBINED INITIAL AND FINAL REPORT. ON OCTOBER 24, 2019 LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A USER FACILITY MEDWATCH FORM FDA 3500A REPORT (0533010000-2019-8008) FROM OUR IMPORTER STATING THAT THERE WAS A REPORTED PATIENT BURN AT (B)(6). (B)(6) REPORTED A PATIENT INCIDENT WITH A LEICA MICROSYSTEMS M320 SURGICAL MICROSCOPE (SERIAL NUMBER (B)(4)) IN JUNE 2019. UPON INTERNAL INVESTIGATION, LEICA MICROSYSTEMS DETERMINED THAT LEICA MICROSYSTEMS HAD NO RECORD OF A REPORTED INCIDENT INVOLVING A M320 SURGICAL MICROSCOPE (SERIAL NUMBER (B)(4)) IN (B)(6) 2019. LEICA MICROSYSTEMS BECAME AWARE OF A PATIENT INCIDENT AT (B)(6) ON (B)(6) 2019. THIS COMPLAINT WAS FOR A REPORTED PATIENT BURN AT (B)(6). THE AFFECTED LEICA SURGICAL MICROSCOPE WAS AN ARVEO (ALSO REFERENCED AS M530 OH6) (SERIAL NUMBER (B)(4)). THIS INCIDENT WAS INVESTIGATED PER LEICA MICROSYSTEMS PROCEDURES AND WAS DETERMINED THAT THE ARVEO SURGICAL MICROSCOPE DEVICE UNLIKELY CAUSED OR CONTRIBUTED TO PATIENT INJURY AND THEREFORE, THE COMPLAINT WAS NOT REPORTABLE TO THE US-FDA IN ACCORDANCE TO 21 CFR 803.50. UPON RECEIPT OF MEDWATCH FORM (0533010000-2019-8008) ON (B)(6) 2019, LEICA MICROSYSTEMS CONTACTED (B)(6) (BIOMEDICAL ENGINEER - UCSF BENIOFF) TO INQUIRE ABOUT THE SOURCE OF THIS COMPLAINT. MR. LAUTENSCHLAGER INDICATED THAT THIS PARTICULAR INCIDENT WAS INVESTIGATED IN AUGUST BY LEICA REPRESENTATIVES. LEICA SALES REPRESENTATIVES WERE CONTACTED AND WERE UNAWARE OF THIS INCIDENT, STATED TO HAVE OCCURRED IN (B)(6) 2019. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE INCIDENT REPORTED IN MEDWATCH (0533010000-2019-8008) WAS FILED IN ERROR AS THIS INCIDENT WAS THE SAME PREVIOUSLY REPORTED TO LEICA MICROSYSTEMS ON (B)(6) 2019. ERRORS IN MEDWATCH FORM (0533010000-2019-8008) INCLUDE: MODEL AND SERIAL NUMBER OF AFFECTED MICROSCOPE. DATE OF INCIDENT. LEICA HAS ASKED MR. LAUTENSCHLAGER TO VERIFY THESE ERRORS AND THE CORRECTED INFORMATION. THIS IS SHOWN IN ATTACHMENT. A MEMO IS ALSO ATTACHED TO CLARIFY THE PRODUCT / DEVICE NAME AS REFERENCED IN THE SUPPORTING DOCUMENTS FOR THE COMPLAINT INVESTIGATION. EXEMPTION NUMBER: E2011008. LEICA MICROSYSTEMS (SCHWEIZ) AG (THE MANUFACTURER) IS ALSO SUBMITTING THE REPORT ON BEHALF OF LEICA MICROSYSTEMS, INC. (THE IMPORTER).

    Description of Event or Problem · 0

    ON OCTOBER 24, 2019 LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A USER FACILITY MEDWATCH FORM FDA 3500A REPORT (0533010000-2019-8008) FROM OUR IMPORTER STATING THAT THERE WAS A REPORTED PATIENT BURN AT THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156650 ARVEO SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other