BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA M844 F40

    MDR report key: 2855734 · Received November 30, 2012

    Report

    Report Number
    3003974370-2012-00014
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. DURING A SURGICAL PROCEDURE, THE ASSISTANT BINOCULAR TUBE FELL ONTO THE PT'S FOREHEAD. THE PT'S UPPER LEFT EYEBROW WAS INJURED (APPROX 20 MM) AND THE PT RECEIVED MEDICAL INTERVENTION (WOUND SUTURE ABOUT 6 TIMES) AND WAS HOSPITALIZED. THE MFR INVESTIGATED THE COMPLAINT. PHOTOGRAPHIC INSPECTION WAS PERFORMED AND RESULTS SHOWED THAT THE MALFUNCTION COULD BE ATTRIBUTED TO AN INTEROPERABILITY PROBLEM MOST LIKELY CAUSED BY ANOTHER DEVICE. AS DESCRIBED IN THE USER MANUAL (LEICA M844 - LEICA M820 / REF. 10 713 294 / VERSION L, P. 25), THE ASSISTANT BINOCULAR TUBE MUST BE CAREFULLY INSERTED TO THE LEICA DOVE TAIL RING AND THE CLAMPING SCREW MUST BE TIGHTENED. THIS MUST BE DONE DURING PREPARATION AND BEFORE A SURGICAL PROCEDURE. HOWEVER, PHOTO SHOWED THAT THE LEICA ASSISTANT BINOCULAR TUBE, WHICH FELL, WAS ATTACHED TO A SURGICAL MICROSCOPE EYE SAFETY FILTER, WHICH IS A DEVICE THAT IS NOT MANUFACTURED BY LEICA. A PHOTO ALSO INDICATES THAT THE SURGICAL MICROSCOPE EYE SAFETY FILTER IS NOT INDICATED FOR USE WITH THE LEICA (B)(4) SURGICAL MICROSCOPE. IN ADDITION, THE SCREW USED WITH THE SURGICAL MICROSCOPE EYE SAFETY FILTER WAS NOT SUPPLIED OR MANUFACTURED BY LEICA.

    Description of Event or Problem · 1

    ON (B)(4) 2012, LEICA MICROSYSTEMS RECEIVED A COMPLAINT STATING THAT THE ASSISTANT BINOCULAR TUBE FELL ONTO THE PT'S FOREHEAD DURING A SURGICAL PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other