BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA M822 F20

    MDR report key: 2904140 · Received January 3, 2013

    Report

    Report Number
    3003974370-2013-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 3, 2012
    Manufacturer
    LEICA MICROSYSTEMS SCHWEIZ AG
    Product Code
    EPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE NURSE, WHO HURT HER BACK, WAS SEEN IN THE EMERGENCY DEPT AND WAS OUT OF WORK FOR A COUPLE OF DAYS. ACCORDING TO THE INITIAL REPORT, THE INJURED NURSE MOVED THE SURGICAL MICROSCOPE FROM THE STORAGE LOCATION TO THE OPERATING ROOM. IN ADDITION, SHE ALSO MOVED THE OPERATING BED 90 DEGREES AND IT IS UNK WHAT HAS CAUSED THE INJURY. FURTHER INVESTIGATION IS STILL BEING CONDUCTED BY THE MFR. ONCE RESULTS OR NEW INFO ARE OBTAINED, A F/U/FINAL FORM FDA 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, LEICE MICROSYSTEMS RECEIVED A COMPLAINT STATING THAT A HEALTH CARE PROFESSIONAL (NURSE) HURT HER BACK WHILE MOVING THE LEICA M822 F20 SURGICAL MICROSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3680 LEICA M822 F20 SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS SCHWEIZ AG M822 F20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other