BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M530 OHX

    MDR report key: 12524245 · Received September 24, 2021

    Report

    Report Number
    3003974370-2021-00017
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    September 14, 2021
    Report Date
    October 1, 2021
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FINAL REPORT. AN INVESTIGATION OF THE REPORTED INCIDENT WAS CONDUCTED AND REVEALED, THAT THE MALFUNCTION WAS DUE TO A BURNT NTC (R15) ON THE VOLTAGE SELECTOR BOARD. TESTS ON A REPRESENTATIVE M530 OHX, A DESIGN REVIEW OF THE ELECTRONIC CIRCUITS INCLUDING COMPONENT SPECIFICATIONS AND AN INVESTIGATION ON THE AFFECTED VOLTAGE SELECTOR BOARD WAS PERFORMED. THE TESTS AND INVESTIGATION REVEALED THAT THE DESIGN IS ADEQUATE AND THE NTC "R15" IS WORKING WITHIN ITS SPECIFIED LIMITS. IT WAS CONCLUDED THAT THE DEFECTIVE COMPONENT NTC "R15" IS AN ISOLATED, RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE AND NO INDICATIONS FOR AN ADVERSE TREND. REPLACING THE VOLTAGE SELECTOR BOARD CORRECTED THE ISSUE AND THE DEVICE WAS FUNCTIONING ACCORDING TO SPECIFICATIONS.

    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 (B)(4) RECEIVED A COMPLAINT FROM USA STATING THAT AN M530 OHX UNEXPECTEDLY SHUT OFF DURING A PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422639 M530 OHX SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG M530 OHX

    Patients

    Seq Age Sex Outcome Treatment
    1