BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA M530 OH6

    MDR report key: 7725434 · Received July 27, 2018

    Report

    Report Number
    3003974370-2018-00007
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    January 17, 2018
    Report Date
    September 10, 2018
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011008. LEICA MICROSYSTEMS (SCHWEIZ) AG (THE MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF LEICA MICROSYSTEMS, INC. (B)(4). THIS IS A FINAL REPORT. LEICA MICROSYSTEMS (SCHWEIZ) AG PERFORMED VISUAL INSPECTION AND FUNCTIONAL TEST ON THE ACTUAL DEVICE. THE RESULTS WERE AS FOLLOWS: THE M530 OH6 HAS BRIGHTCARE PROTECTION INSTALLED WHICH REDUCES THE LIGHT INTENSITY AUTOMATICALLY AS THE WORKING DISTANCE DECREASES. THIS MINIMIZES POTENTIAL INCIDENTS OF PATIENT BURNS. THIS SYSTEM ENGAGES BY DEFAULT UPON MICROSCOPE STARTUP. THE BRIGHTCARE SYSTEM WAS SHOWN TO BE ACTIVE UPON EXAMINATION AND FUNCTIONING PROPERLY. ALL FILTERS WERE IN THE PROPER LOCATION WITHIN THE M530 OH6 AND WERE SHOWN TO BE FUNCTIONING CORRECTLY. AN EXAMINATION OF THE INFRARED (IR) HEAT PROTECTION FILTER SHOWED, THAT THE IR FILTER OF THE M530 OH6 FUNCTIONED ACCORDING TO SPECIFICATIONS. A CHECK OF THE DEVICE HISTORY RECORD SHOWED THAT THE DEVICE WAS FUNCTIONING ACCORDING TO SPECIFICATIONS AND REVEALED NO ANOMALIES DURING MANUFACTURING, IN-PROCESS CONTROLS AND FINAL ACCEPTANCE TEST. A REVIEW OF THE COMPLAINT DATABANK SHOWED, THAT LEICA MICROSYSTEMS (SCHWEIZ) AG IS NOT AWARE OF ANY OTHER SIMILAR INCIDENT SINCE INTRODUCTION OF THE M530 OH6. BASED ON THE INVESTIGATION RESULTS AND THE REVIEW OF THE COMPLAINT DATABANK WE CONCLUDE, THAT THE M530 OH6 FUNCTIONS CORRECTLY AND THAT IT IS HIGHLY UNLIKELY THAT IT CAUSED OR CONTRIBUTED TO THE INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2018, LEICA MICROSYSTEMS ((B)(6)) AG RECEIVED A COMPLAINT FROM THE (B)(6) STATING THAT THREE (3) PATIENTS HAD SKIN ULCERATIONS AND ONE (1) PATIENT HAD THERMAL BURN IMMEDIATELY FOLLOWING SURGERY. FOR THIS REPORT ONE PATIENT HAD SKIN ULCERATION IMMEDIATELY FOLLOWING SURGERY. SEE MANUFACTURER/IMPORTER REPORT NUMBERS: 3003974370-2018-00008 / 3003974370-2018-00009 / 3003974370-2018-00010 FOR INFORMATION REGARDING THE OTHER THREE (3) PATIENTS REPORTED IN THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567402 LEICA M530 OH6 SURGIAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG

    Patients

    Seq Age Sex Outcome Treatment
    1 20 DA Required Intervention