BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIAMOND KNIFE

    MDR report key: 2097527 · Received May 16, 2011

    Report

    Report Number
    MW5020633
    Event Type
    Other
    Date Received
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    DSP INC.
    Product Code
    HNN
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DSP INCORPORATED. WWW.DIAMONDSURGICALPRODUCTS.COM. THIS COMPANY SELLS SURGICAL EYE INSTRUMENTATION WITH ANY IFUS. I'VE REQUESTED CLEANING AND STERILIZATION INSTRUCTIONS AND THERE WERE NONE AVAILABLE. THIS IS WHAT IS PROVIDED ON THEIR WEBSITE: PRE-STERILIZATION: YOUR DSP DIAMOND KNIFE SHOULD BE CLEANED WITH THE BLADE IN THE EXTENDED POSITION (IN THE EXTENDED POSITION CARE MUST BE TAKEN NOT TO TOUCH THE BLADE TO ANY HARD SURFACE) BY HOLDING IT 6-12 INCHES BELOW THE NOZZLE ON A STEAM CLEANER. COMPRESSED OR HOT AIR (HAIRDRYER) SHOULD BE USED TO DRY THE DIAMOND KNIFE. STERILIZATION: STERILIZING MAY BE PERFORMED BY STEAM AUTOCLAVING (NOT TO EXCEED 275 DEGREES FAHRENHEIT) OR GAS. A CONVENIENT STERILIZING TRAY HAS BEEN PROVIDED WITH YOUR KNIFE. MAKE SURE THE BLADE IS RETRACTED BEFORE PLACING IT INTO THE TRAY. CONSULT YOUR INSTITUTION'S GUIDELINES FOR STERILIZATION PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND KNIFE DIAMOND KNIFE HNN DSP INC. XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other