BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M525 F20

    MDR report key: 11936760 · Received June 4, 2021

    Report

    Report Number
    3003974370-2021-00009
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 19, 2021
    Report Date
    July 12, 2021
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FINAL REPORT. AN INVESTIGATION OF THE REPORTED INCIDENT WAS CONDUCTED. THE INVESTIGATION CONCLUDES, THAT THE ISSUE IS CAUSED BY AN ISOLATED ELECTRONIC FAILURE IN A DEVICE WHICH IS MORE THAN 11 YEARS OLD. THE 6.3 MAINS FUSES OPERATED UNEXPECTEDLY. THE ISSUE IS CONSIDERED AN ISOLATED COMPONENT FAILURE WITH NO INDICATION FOR AN ADVERSE TREND. THE AFFECTED XENON POWER SUPPLY WAS REPLACED.

    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

    LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM (B)(6) STATING THAT DURING A SURGICAL PROCEDURE BOTH 6.3A MAINS FUSES OPERATED UNEXPECTEDLY AND SUBSEQUENTLY THE M525 F20 HAD A TOTAL LOSS OF FUNCTION. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836463 M525 F20 SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG M525 F20

    Patients

    Seq Age Sex Outcome Treatment
    1