BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M530 OHX

    MDR report key: 22370366 · Received July 1, 2025

    Report

    Report Number
    3003974370-2025-00005
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    April 24, 2025
    Report Date
    September 3, 2025
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    UDI-DI
    07630003579642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THIS IS A FINAL REPORT. AN INVESTIGATION WAS PERFORMED ON THE RETURNED PART. THE AFFECTED SCREW WAS ANALYZED BY AN INDEPENDENT LABORATORY. THE EXAMINATION INCLUDED A VISUAL INSPECTION, A MICROSCOPIC EXAMINATION, AND A SCANNING ELECTRON MICROSCOPE ANALYSIS. ADDITIONALLY, LEICA MICROSYSTEMS (SCHWEIZ) AG CONDUCTED A DESIGN REVIEW OF THE SWING ARM BASED ON THE INDEPENDENT LABORATORY REPORT. NO EVIDENCE OF THE REPORTED MALFUNCTION WAS FOUND. THE SCREW BROKE AT THE JOINT BETWEEN THE ARM AND THE STRUT (BALL BEARING WITH BUSHING). THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED. DIFFERENT FACTORS COULD HAVE CONTRIBUTED TO THE FAILURE. HOWEVER, IT IS SUSPECTED THAT ORGANIC CONTAMINANTS ENTERED THE BALL BEARING OVER TIME, CAUSING THE BUSHING TO STICK OR JAM. WHEN THE ARM WAS MOVED, TORQUE WAS TRANSFERRED THROUGH THE BALL BEARING TO THE SLEEVE AND THEN TO THE SCREW, RESULTING IN ABRASION AND EVENTUAL FAILURE. A REVIEW OF THE SERVICE RECORDS AND ASSEMBLY INSTRUCTIONS REVEALED NO EVIDENCE OF PROBLEMS THAT COULD BE ASSOCIATED WITH THE REPORTED INCIDENT. A REVIEW OF THE COMPLAINT STATISTICS DID NOT SHOW ANY SIMILAR OR IDENTICAL CASE. THE REPORTED MALFUNCTION IS CONSIDERED AN ISOLATED EVENT AND DOES NOT INDICATE A DESIGN OR MANUFACTURING ISSUE. THE BROKEN SCREW WAS REPLACED WITH A NEW ONE ACCORDING TO RELEASED SERVICE PROCEDURES. THE M530 OHX SYSTEM HAS BEEN TESTED AND IS OPERATING ACCORDING TO SPECIFICATIONS. ADDITIONAL INFORMATION: IN THE INITIAL REPORT, THE CONTACT DETAILS OF THE INITIAL REPORTER WERE UNKNOWN. THIS FINAL REPORT PROVIDES THE MISSING INFORMATION; SEE SECTIONS E.1, E.2 AND E.3.

    Description of Event or Problem · 0

    LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM CHINA STATING THAT THE HORIZONTAL ARM OF AN M530 OHX CAME LOOSE. THERE WAS NO PATIENT / USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381072 M530 OHX SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG 10448737 07630003579642

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown