BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M530 OHX

    MDR report key: 16633247 · Received March 29, 2023

    Report

    Report Number
    3003974370-2023-00006
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    March 23, 2023
    Report Date
    June 30, 2023
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FINAL REPORT. AN ON-SITE INVESTIGATION WAS PERFORMED BY A LEICA FIELD SERVICE ENGINEER. AFTER REMOVING AND RECONNECTING THE LEFT AND RIGHT HANDLE SWITCHBOARDS, THE MICROSCOPE RESUMED ITS NORMAL FUNCTION. THE MICROSCOPE WAS EXAMINED FOR SEVERAL HOURS AND THE DEVICE DID NOT SHOW ANY MALFUNCTION. THE FSE CONFIRMED THAT NO DEFECTIVE PARTS NEEDED TO BE REPLACED. WE SUSPECT THE CABLE WAS GROUNDED TO ONE OF THE HANDLES. MOST LIKELY THE GROUND WIRE WAS PINCHED ON THE CAN HANDLE AND CONNECTED TO THE METAL CASE CAUSING A GROUND. RECONNECTING THE LEFT AND RIGHT HANDLE SWITCHBOARDS EFFECTIVELY SOLVED THE PROBLEM.

    Additional Manufacturer Narrative · 0

    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 · 0

    LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM INDIA STATING THAT A M530 OHX HAD A LOSS OF ILLUMINATION AND OTHER FUNCTIONS DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713848 M530 OHX SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG M530 OHX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown