BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA FOOTSWITCH

    MDR report key: 2024240 · Received March 10, 2011

    Report

    Report Number
    3003974370-2011-00002
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    January 12, 2010
    Report Date
    January 12, 2010
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Removal / Correction Number
    #Z1632/1633-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: (B)(6), 2010. THE FIRST COMPLAINT WAS REC'D FROM THE INITIAL REPORTER AND STATED THAT THE PEDALS OF THE FOOTSWITCH/WIRELESS TYPE B WERE STICKING AND THE ZOOM/FOCUS WAS MOVING TO THE END POSITION. AS OF (B)(6), 2010, LEICA REC'D A TOTAL OF TWELVE (12) SIMILAR COMPLAINTS CONCERNING THE FOOTSWITCH. WHEN THE FOCUS IS MOVING TO THE LOWER END POSITION AND A BIOM (NON-LEICA ACCESSORY) OR ANY OTHER NON-CONTACT VIEWING SYSTEM IS USED IN COMBINATION WITH AN OPHTHALMOLOGY MICROSCOPE, THE BIOM CAN MOVE INTO THE PT'S EYE. INVESTIGATION DETERMINED THAT THE FOOTSWITCH PEDAL WAS UNDERSIZED DUE TO A CONTRACT MANUFACTURER'S SUPPLIER CHANGE .PLEASE SEE ATTACHED LETTERS, "RECALL OF SURGICAL MICROSCOPE FOOTSWITCH" (DATE (B)(6), 2010) WHICH WERE SENT TO THE USFDA. A LETTER OF ACKNOWLEDGEMENT (DATED (B)(6), 2010) FROM THE USFDA IS ALSO ATTACHED. FIFTY-TWO (52) AFFECTED FOOTSWITCHES WERE DISTRIBUTED IN THE USA. IN ADDITION, TWO (2) AND SIX (6) AFFECTED FOOTSWITCHES WERE DISTRIBUTED IN (B)(6). ALL SIXTY (60) AFFECTED FOOTSWITCHES HAVE BEEN EITHER UPGRADED OR REPLACED. A REQUEST FOR CLOSURE OF THE FOOTSWITCH RECALL (RECALL #Z1632/1633-2010) WAS SUBMITTED AND IS STILL PENDING.

    Description of Event or Problem · 1

    LEICA REC'D TWELVE (12) COMPLAINTS STATING THAT THE PEDALS OF THE FOOTSWITCH TYPE B IS STICKING AND THE ZOOM/FOCUS IS MOVING TO THE END POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA FOOTSWITCH FOOTSWITCH FOR SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG TYPE B

    Patients

    Seq Age Sex Outcome Treatment
    1