BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M530 OHX

    MDR report key: 11336395 · Received February 17, 2021

    Report

    Report Number
    3003974370-2021-00003
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 19, 2021
    Report Date
    May 7, 2021
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FINAL REPORT. AN INVESTIGATION OF THE REPORTED INCIDENT WHERE THE ILLUMINATION OF AN M530 OHX SHUT OFF DURING SURGERY WAS CONDUCTED. AN INITIAL INVESTIGATION PERFORMED BY THE FSE ON THE ACTUAL DEVICE REVEALED, THAT THE ILLUMINATION SHUT DOWN WITH A LAMP DEFECTIVE ERROR. THE UNIT CONTINUED TO WORK DESPITE A DEFECTIVE COMPONENT (OVERHEATED NTC "R15") ON THE BOARD. REPLACING THE VOLTAGE SELECTOR BOARD CORRECTED THE ISSUE AND THE DEVICE WAS FUNCTIONING ACCORDING TO SPECIFICATIONS. A REVIEW OF THE COMPLAINT DATABASE AND THE SPARE PART CONSUMPTION WAS PERFORMED. THE REVIEW DID NOT REVEAL INDICATIONS FOR AN ADVERSE TREND. 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. BASED ON THE RESULTS OF THE INVESTIGATION THE IDENTIFIED ROOT CAUSE IS A DEFECTIVE COMPONENT, I.E. NTC "R15" ON THE VOLTAGE SELECTOR BOARD. THE ISSUE IS CONSIDERED AN ISOLATED, RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE WITH NO INDICATIONS OF AN ADVERSE TREND.

    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)(6)) (B)(4) RECEIVED A COMPLAINT FROM (B)(6) STATING THAT THE ILLUMINATION OF THE M530 OHX SHUT OFF DURING SURGERY. THERE WAS A LAMP DEFECTIVE ERROR AND A BURN SMELL COMING OUT OF THE UNIT. THE DEVICE STILL CONTINUED TO WORK AFTER RESTART. THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235561 M530 OHX SURGIAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG M530 OHX

    Patients

    Seq Age Sex Outcome Treatment
    1