BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2043086 · Received March 25, 2011

    Report

    Report Number
    2523835-2011-00023
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HNN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE A SAMPLE WAS NOT RETURNED, THE ROOT CAUSE FOR THE DULL KNIFE EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE KNIFE WAS NOT SHARP ENOUGH TO CUT THROUGH THE PT'S CONJUNCTIVA. THE KNIFE WAS SWITCHED OUT AND THE CASE WAS COMPLETED. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982665 824586M

    Patients

    Seq Age Sex Outcome Treatment
    1