BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA M525 F40

    MDR report key: 2024270 · Received March 10, 2011

    Report

    Report Number
    3003974370-2011-00006
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    December 26, 2009
    Report Date
    December 27, 2009
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: SCREW HOLES. BASED ON PHOTOS REC'D FROM CUSTOMER, A PRELIMINARY ANALYSIS WAS PERFORMED AND SHOWED THAT THE A BEARING SLIDE HAD DETACHED FROM THE A BEARING RAIL. AS A RESULT, THE BALL BEARING IS MISSING FROM THE BEARING SLIDE. TO DETACH THE BEARING, SLIDE MUST MOVE 10MM BEYOND THE END OF THE BEARING RAIL TO TOTALLY DISENGAGE. MOREOVER, CA 16MM OF THREAD ENGAGEMENT IS AVAILABLE BEFORE THE BEARING SLIDE TOUCHED THE COVER A. TO SIMULATE THE FAILURE, IT TOOK APPROX 3 3/4 TURNS AT A SLIDE BEFORE THE SPINDLE DISENGAGED. RESULTS ALSO SHOWED THAT IT REQUIRES A STRONG FORCE OF 4 NM TO PUSH THE A-SLIDE OUT, WHICH IS COMPARED TO 2 NM TO PUSH IT BY HAND. HENCE, THE DESIGN IS ROBUST FOR NORMAL USAGE. UPON INSPECTION OF THE RETURNED COVER A, IT HAS BEEN DETERMINED THAT THE SCREW HOLE IN COVER A IS OUT OF SPECIFICATION. THE DIAMETER OF THE SCREW HOLE IN THE RETURNED COVER A WAS LARGER THAN IN THE DRAWING SPECIFICATION. THIS CAN CONTRIBUTE TO A MINIMAL DAMAGE ON THE COVER WHEN A SMALL FORCE IS APPLIED. IN CONCLUSION, LEICA'S INVESTIGATION IDENTIFIED THAT THE DIAMETER OF COVER A SCREW HOLES WAS OUT OF SPECIFICATION AND CONTRIBUTED INDIRECTLY TO THE EVENT. ADDITIONALLY, A STRONG FORCE MUST HAVE BEEN APPLIED (MISUSE) TO PUSH THE A-SLIDE OUT AND EVENTUALLY DISENGAGE THE OPTICS CARRIER FROM THE ARM, CAUSING THE OPTICS CARRIER TO FALL.

    Description of Event or Problem · 1

    ON (B)(4) 2009, LEICA MICROSYSTEMS REC'D A COMPLAINT FROM A CUSTOMER STATED THAT DURING A SURGICAL PROCEDURE, THE MICROSCOPE'S OPTICS CARRIER FELL DOWN. NO PT WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA M525 F40 SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG M525 F40

    Patients

    Seq Age Sex Outcome Treatment
    1