BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA M844 F40

    MDR report key: 2081225 · Received May 2, 2011

    Report

    Report Number
    3003974370-2011-00014
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    November 29, 2010
    Report Date
    March 23, 2011
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BINOCULAR LENS. LEICA RECEIVED A COMPLAINT STATING THAT BEFORE A CATARACT SURGERY, THE BINOCULAR OF LEICA (B)(4) FELL ON THE PATIENT'S HEAD. TWO SUTURES WERE REQUIRED TO CLOSE THE WOUND ON THE PATIENT'S HEAD. THE CATARACT SURGERY WAS PERFORMED AS PLANNED. THE PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS MALFUNCTION. ACCORDING TO THE DISTRIBUTOR, THE CASE IS RESOLVED. FURTHER INVESTIGATION WAS CONDUCTED BY THE MANUFACTURER. BASED ON THE DESIGN OF THE OPTICS CARRIER, THE BINOCULAR TUBE IS SECURELY MOUNTED BY A CLAMPING SCREW. THE MALFUNCTION WAS ALSO SIMULATED BY THE MANUFACTURER. IT WAS SHOWN THAT IF THE BINOCULAR TUBE IS NOT PROPERLY MOUNTED (E.G. CLAMPING SCREW HOLDING THE BINOCULAR TUBE IS NOT TIGHTENED), THE BINOCULAR TUBE COULD FALL. INFORMATION REGARDING THE ROOT CAUSE OF THE MALFUNCTION WAS REQUESTED BY THE MANUFACTURER FROM THE DISTRIBUTOR. THE MALFUNCTION OCCURRED ON (B)(6) 2010 AND WAS NOT REPORTED DIRECTLY BY THE SURGEON OR HEALTHCARE PROFESSIONAL. THE DISTRIBUTOR'S REPRESENTATIVE WAS INFORMED BY THE CUSTOMER MORE THAN 3 MONTHS AFTER THE MALFUNCTION HAS OCCURRED AND LIMITED INFORMATION HAS BEEN OBTAINED. ACCORDING TO THE DISTRIBUTOR, THE ROOT CAUSE CANNOT BE IDENTIFIED. HENCE, A CONCLUSION CANNOT BE DRAWN DUE TO THE LIMITED INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011 LEICA RECEIVED A COMPLAINT STATING THAT BEFORE CATARACT SURGERY, THE BINOCULAR FELL ON PATIENT'S HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA M844 F40 SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention